K093877 is an FDA 510(k) clearance for the RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 1, 2010, 197 days after receiving the submission on December 16, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K093877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2009 |
| Decision Date | July 01, 2010 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |