FDA 510(k) Applications for Medical Device Product Code "DXE"
(Catheter, Embolectomy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972572 | AMERICAN BIOMED, INC. | SINGLE LUMEN EMBOLECTOMY CATHETER | 01/13/1998 |
| K971314 | ANGIODYNAMICS, INC. | DCAT EMBOLECTOMY CATHETER SYSTEM | 03/17/1998 |
| K970762 | APPLIED MEDICAL RESOURCES | DUAL LUMEN EMBOLECTOMY CATHETER | 03/28/1997 |
| K973465 | APPLIED MEDICAL RESOURCES | LATIS GRAFT CLEANING CATHETER | 02/19/1998 |
| K202049 | Applied Medical Resources Corporation | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | 09/07/2021 |
| K982141 | ARROW INTL., INC. | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 | 08/31/1998 |
| K002627 | ATRIUM MEDICAL CORP. | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | 04/26/2001 |
| K020634 | ATRIUM MEDICAL CORP. | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | 05/08/2002 |
| K163031 | COOK INCORPORATED | Bunegin-Albin Air Aspiration Set | 07/27/2017 |
| K163353 | Cook Incorporated | Needle's Eye Snare Retrieval Set - 54cm | 07/11/2017 |
| K961992 | COOK PACEMAKER CORP. | NEEDLE'S EYE SNARE | 12/27/1996 |
| K193379 | Edwards Lifesciences, LLC | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | 06/12/2020 |
| K100840 | HOTSPUR TECHNOLOGIES | EMBO PLUS EMBOLECTOMY CATHETER | 07/12/2010 |
| K100842 | HOTSPUR TECHNOLOGIES | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | 07/12/2010 |
| K961716 | IDEAS FOR MEDICINE, INC. | VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE | 09/19/1996 |
| K961883 | IDEAS FOR MEDICINE, INC. | VERSA-CATH ARTERIAL CATHETER | 01/13/1997 |
| K974335 | J-LLOYD MEDICAL, INC. | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | 02/13/1998 |
| K022145 | LEMAITRE VASCULAR, INC. | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | 01/14/2003 |
| K954760 | LUCAS MEDICAL, INC. | LMI ARTERIAL EMBOLECTOMY CATHETER | 04/11/1996 |
| K972623 | LUCAS MEDICAL, INC. | LMI IRRIGATION CATHETER (IGR) | 11/19/1997 |
| K955125 | LUCAS MEDICAL, INC. | LMI OCCLUSION CATHETER | 03/11/1996 |
| K970657 | LUCAS MEDICAL, INC. | LMI THROMBECTOMY CATHETER | 07/01/1997 |
| K081573 | MEDTRONIC VASCULAR | MEDTRONIC EXPORT AP CATHETER | 06/27/2008 |
| K152335 | Medtronic, Inc. | Export Advance Aspiration Catheter | 09/18/2015 |
| K972511 | MICROVENA CORP. | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | 03/06/1998 |
| K213771 | MIVI Neurovascular, Inc. | Merlin Aspiration System | 01/27/2022 |
| K011783 | PFM PRODUKTE FUR DIE MEDIZIN AG | MULTI-SNARE SET | 01/24/2002 |
| K973477 | SUNSCOPE INTL., INC. | BIOSENSORS EMBOLECTOMY CATHETER | 09/04/1998 |
| K992940 | VASCUTECH, INC. | LEMAITRE BALLOON CATHETER WITH IRRIGATION | 02/22/2000 |
| K992368 | VASCUTECH, INC. | LEMAITRE EMBOLECTOMY CATHETER | 12/09/1999 |
| K992933 | VASCUTECH, INC. | LEMAITRE IRRIGATION CATHETER | 03/08/2000 |
| K992934 | VASCUTECH, INC. | LEMAITRE VENOUS THROMBECTOMY CATHETER | 03/01/2000 |
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