K022145 is an FDA 510(k) clearance for the OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 14, 2003, 196 days after receiving the submission on July 2, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K022145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2002 |
| Decision Date | January 14, 2003 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |