[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PTT":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":34,"syncDates":55},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":29,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":30,"pma_count":30,"event_count":30},3072,"PTT","Biliary Catheter For Irrigation And Contrast Injection, Exempt","2","876.5010","GU","Gastroenterology, Urology","4","This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"fei_number":17,"registration_number":24},[18,19,20,21,22,23],"1000237915","3006082230","3010011359","3008797804","2939142","1018233",[19,20,21,22,23,25],"9611590","","N","Ineligible","2026-08-18T05:52:50.955415+00:00",0,null,[],[],[35,39,43,47,51],{"product_code":36,"device_name":37,"device_class":8,"k510_count":38},"FGE","Stents, Drains And Dilators For The Biliary Ducts",476,{"product_code":40,"device_name":41,"device_class":8,"k510_count":42},"LQR","Dislodger, Stone, Biliary",38,{"product_code":44,"device_name":45,"device_class":8,"k510_count":46},"GCA","Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection",26,{"product_code":48,"device_name":49,"device_class":8,"k510_count":50},"EXF","Bag, Bile Collecting",9,{"product_code":52,"device_name":53,"device_class":8,"k510_count":54},"NML","Catheter, Biliary, Reprocessed",1,{"510k":56,"classification":57,"enforcement":58,"event":59,"pma":60,"warning_letter":61},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]