K041453 is an FDA 510(k) clearance for the SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023. This device is classified as a Stripper, Vein, External (Class II - Special Controls, product code DWQ).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on July 22, 2004, 51 days after receiving the submission on June 1, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K041453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2004 |
| Decision Date | July 22, 2004 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWQ — Stripper, Vein, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |