DXE · Catheter, Embolectomy
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | DXE |
|---|---|
| Device Name | Catheter, Embolectomy |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | Aug 28, 2024 | SESE |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | Jul 2, 2024 | SESE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | May 22, 2024 | SESE |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | May 22, 2024 | SESE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | May 20, 2024 | SESE |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | Jan 27, 2022 | SESE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | Sep 7, 2021 | SESE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | Jun 12, 2020 | SESE |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | Jul 27, 2017 | SESE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | Jul 11, 2017 | SESE |
| K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | Sep 18, 2015 | SESE |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | Hotspur Technologies | Jul 12, 2010 | SESE |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | Jul 12, 2010 | SESE |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | Jun 27, 2008 | SESE |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | Jan 14, 2003 | SESE |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | May 8, 2002 | SESE |
| K011783 | MULTI-SNARE SET | Pfm Produkte Fur Die Medizin AG | Jan 24, 2002 | SESE |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | Apr 26, 2001 | SESE |
| K992933 | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | Mar 8, 2000 | SESE |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | Mar 1, 2000 | SESE |
Top Applicants
- Shiley, Inc. — 5 clearances
- Cathlab Corp. — 4 clearances
- Ideas For Medicine, Inc. — 4 clearances
- Lucas Medical, Inc. — 4 clearances
- Vascutech, Inc. — 4 clearances
