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Dilator, Vessel, For Percutaneous Catheterization（DRE）
経皮的カテーテル挿入用血管拡張器 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
39 件
直近 2025.05.14
105 件
0 件
3,178 件
分類情報
| Product Code | DRE |
|---|---|
| デバイス名 | Dilator, Vessel, For Percutaneous Catheterization 経皮的カテーテル挿入用血管拡張器 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 870.1310 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 循環器 |
| 定義 | － |
| フラグ | 該当なし |
| AI分析 | この機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）の対象となる医療機器です。クラスIIは中程度のリスクを有する機器区分であり、既存の同等な機器（同等性）を示すことで市販前承認（PMA）のような厳格な審査を経ずに市販が可能となります。 米国市場での動向 本製品は510(k)による市販前届出品目で、累計届出件数は約100件、参入企業数は約70社、直近5年間の届出は約10件となっています。不具合報告は累計約3,100件で、死亡が184件、傷害が約1,600件と、不具合（Malfunction）の約1,300件よりも死亡・傷害の比率が高く、主な問題として破損（Fracture）、機器または機器部品の脱離（Detachment of Device or Device Component）、物理的抵抗・スティッキング（Physical Resistance/Sticking）が挙げられています。回収は累計約40件で、クラスIが1件、クラスIIが約30件、クラスIIIは確認されておらず、直近5年では約20件、最新の回収は2026年6月に開始されています。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 医療用拡張器 | カテーテル拡張器クラスⅡ | 33 | 19 | 10.61 億円/年 | +9.7% | 8,428 円/個 | 38.1% |
| 2 | 医療用嘴管及び体液誘導管 | 経皮泌尿器用カテーテルクラスⅡ | 19 | 11 | 5.53 億円/年 | -0.6% | 2.23 万円/個 | 0.0% |
| 3 | 医療用嘴管及び体液誘導管 | バルーン拡張式血管形成術向けカテーテル用コネクタクラスⅡ | 41 | 23 | 23.24 億円/年 | +25.9% | 1,287 円/個 | 76.6% |
| 4 | 医療用嘴管及び体液誘導管 | 経皮洗浄向け泌尿器用カテーテルクラスⅡ | — | — | — | — | — | — |
| 5 | 医療用嘴管及び体液誘導管 | バルーン拡張式血管形成術用カテーテルクラスⅣ | 132 | 31 | 212.4 億円/年 | +5.8% | 4.06 万円/個 | 40.9% |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 39 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1732-2025 DRE | クラス II | 2025.03.27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging . | 対応中 |
| Z-3190-2024 DRE | クラス II | 2024.08.12 | Merit Medical Systems, Inc. | 7F sheath introducers labeled as 7.5F | 対応中 |
| Z-1348-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1347-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1346-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1345-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1344-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1343-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1342-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1341-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1340-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1339-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1338-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1337-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1336-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1335-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-1334-2024 DRE | クラス II | 2024.01.30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case | 対応中 |
| Z-2079-2021 DRE | クラス II | 2021.06.09 | Cordis Corporation | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. | 終了 |
| Z-1486-2021 DRE | クラス II | 2021.03.19 | Cardiac Assist, Inc | On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field. | 終了 |
| Z-2806-2020 DRE | クラス II | 2020.06.19 | Argon Medical Devices, Inc | Sterile introducer sheath set manufactured under one lot with different expiration dates. | 終了 |
510(k)（市販前届出）
全 105 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026.07.27 | 通常（Traditional） | |
| 2 | K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025.12.19 | 特別（Special） | |
| 3 | K251325 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2025.05.29 | 特別（Special） | |
| 4 | K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025.01.15 | 通常（Traditional） | |
| 5 | K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2024.07.12 | 特別（Special） | |
| 6 | K233647 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2023.12.14 | 特別（Special） | |
| 7 | K232609 | Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. | 2023.09.27 | 特別（Special） | |
| 8 | K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | Spectranetics, Inc. | 2022.12.15 | 特別（Special） | |
| 9 | K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022.08.24 | 通常（Traditional） | |
| 10 | K211679 | Xtractor device | Xcardia Innovation , Ltd. | 2022.02.17 | 通常（Traditional） | |
| 11 | K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021.04.06 | 特別（Special） | |
| 12 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020.06.12 | 特別（Special） | |
| 13 | K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | 2020.05.06 | 通常（Traditional） | |
| 14 | K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020.03.19 | 特別（Special） | |
| 15 | K192195 | Sterile Dilator | Galt Medical Corp. | 2019.09.26 | 特別（Special） | |
| 16 | K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019.04.10 | 通常（Traditional） | |
| 17 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019.03.21 | 通常（Traditional） | |
| 18 | K183036 | Dilator Sets | Cook Incorporated | 2018.12.20 | 通常（Traditional） | |
| 19 | K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018.10.29 | 通常（Traditional） | |
| 20 | K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017.10.16 | 通常（Traditional） |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。