K033159 is an FDA 510(k) clearance for the LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on December 19, 2003, 80 days after receiving the submission on September 30, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K033159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | December 19, 2003 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MJN — Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |