FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K210660 |
Anrei Medical (Hangzhou) Co., Ltd. |
Stone Retrieval Balloon Catheter |
04/27/2021 |
K212582 |
Boston Scientific Corporation |
SpyGlass Discover Balloon Dilation Catheter |
05/06/2022 |
K173414 |
Cook Incorporated |
Advance Biliary Balloon Catheter |
06/22/2018 |
K980917 |
FORTUNE MEDICAL INSTRUMENT CORP. |
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR |
05/27/1998 |
K200173 |
Hangzhou AGS MedTech Co., Ltd. |
Stone Retrieval Balloon |
05/01/2020 |
K011018 |
TAUT, INC. |
TAUT BALLOON CATHETER, MODEL 50640 |
06/22/2001 |
K193344 |
Wilson-Cook Medical Inc. |
Tri-Ex Extraction Balloon with Multiple Sizing |
12/13/2019 |
K200247 |
Wilson-Cook Medical, Inc |
Fusion Quattro Extraction Balloon |
02/27/2020 |
K173659 |
Wilson-Cook Medical, Inc |
Howell D.A.S.H Extraction Balloon with Multiple Sizing |
07/06/2018 |
K170292 |
WILSON-COOK MEDICAL, INC |
Tri-Ex Extraction Balloon With Multiple Sizing |
09/20/2017 |
K063677 |
WILSON-COOK MEDICAL, INC. |
FUSION QUATTRO EXTRACTION BALLOON XL |
01/05/2007 |
K040129 |
WILSON-COOK MEDICAL, INC. |
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING |
02/27/2004 |