K032041 is an FDA 510(k) clearance for the DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM). This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on August 27, 2003, 57 days after receiving the submission on July 1, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K032041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2003 |
| Decision Date | August 27, 2003 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |