Product code DXE
- Device name
- Catheter, Embolectomy
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5150
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | 2024-08-28 |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | 2024-07-02 |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | 2024-05-22 |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | 2024-05-22 |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | 2024-05-20 |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | 2022-01-27 |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | 2021-09-07 |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | 2020-06-12 |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | 2017-07-27 |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | 2017-07-11 |
| K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015-09-18 |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | 2010-07-12 |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | Hotspur Technologies | 2010-07-12 |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | 2008-06-27 |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | 2003-01-14 |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2002-05-08 |
| K011783 | MULTI-SNARE SET | Pfm Produkte Fur Die Medizin AG | 2002-01-24 |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2001-04-26 |
| K992933 | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | 2000-03-08 |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | 2000-03-01 |
| K992940 | LEMAITRE BALLOON CATHETER WITH IRRIGATION | Vascutech, Inc. | 2000-02-22 |
| K992368 | LEMAITRE EMBOLECTOMY CATHETER | Vascutech, Inc. | 1999-12-09 |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | Sunscope Intl., Inc. | 1998-09-04 |
| K982141 | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 | Arrow Intl., Inc. | 1998-08-31 |
| K971314 | DCAT EMBOLECTOMY CATHETER SYSTEM | AngioDynamics, Inc. | 1998-03-17 |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | Microvena Corp. | 1998-03-06 |
| K973465 | LATIS GRAFT CLEANING CATHETER | Applied Medical Resources | 1998-02-19 |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | J-Lloyd Medical, Inc. | 1998-02-13 |
| K972572 | SINGLE LUMEN EMBOLECTOMY CATHETER | American Biomed, Inc. | 1998-01-13 |
| K972623 | LMI IRRIGATION CATHETER (IGR) | Lucas Medical, Inc. | 1997-11-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08886483504455 | Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 08886483504486 | Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 08886483504516 | Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-04 |
| 10801902196603 | ARROW | TELEFLEX INCORPORATED | 2022-11-15 |
| 10801902196610 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194104 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194098 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194081 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194074 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194067 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194050 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 10801902194043 | ARROW | TELEFLEX INCORPORATED | 2022-11-08 |
| 08714729904724 | AngioJet™ ZelanteDVT™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729889663 | AngioJet™ Solent™ Omni | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10801902121254 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121315 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121308 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121292 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121285 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121278 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121261 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902121247 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 08888893235127 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235103 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235097 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235059 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235042 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235035 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235011 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |
| 08888893235004 | Biosensors Embolectomy Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2016-09-01 |