DXE — Catheter, Embolectomy Class II
FDA product code DXE covers "Catheter, Embolectomy", a Class II medical device regulated under 21 CFR 870.5150. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXE
- Device Class
- Class II
- Regulation Number
- 870.5150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240078 | edwards lifesciences | Fogarty Thru-Lumen Embolectomy Catheter | August 28, 2024 |
| K241330 | edwards lifesciences | Fogarty Fortis Arterial Embolectomy Catheter | July 2, 2024 |
| K233820 | edwards lifesciences | Fogarty Arterial Embolectomy Catheter with Gate Valve | May 22, 2024 |
| K233819 | edwards lifesciences | Fogarty Venous Thrombectomy Catheters | May 22, 2024 |
| K233619 | edwards lifesciences | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | May 20, 2024 |
| K213771 | mivi neurovascular | Merlin Aspiration System | January 27, 2022 |
| K202049 | applied medical resources corporation | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | September 7, 2021 |
| K193379 | edwards lifesciences | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | June 12, 2020 |
| K163031 | cook incorporated | Bunegin-Albin Air Aspiration Set | July 27, 2017 |
| K163353 | cook incorporated | Needle's Eye Snare Retrieval Set - 54cm | July 11, 2017 |
| K152335 | medtronic | Export Advance Aspiration Catheter | September 18, 2015 |
| K100840 | hotspur technologies | EMBO PLUS EMBOLECTOMY CATHETER | July 12, 2010 |
| K100842 | hotspur technologies | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | July 12, 2010 |
| K081573 | medtronic vascular | MEDTRONIC EXPORT AP CATHETER | June 27, 2008 |
| K022145 | lemaitre vascular | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | January 14, 2003 |
| K020634 | atrium medical | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | May 8, 2002 |
| K011783 | pfm produkte fur die medizin | MULTI-SNARE SET | January 24, 2002 |
| K002627 | atrium medical | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | April 26, 2001 |
| K992933 | vascutech | LEMAITRE IRRIGATION CATHETER | March 8, 2000 |
| K992934 | vascutech | LEMAITRE VENOUS THROMBECTOMY CATHETER | March 1, 2000 |