K131627 is an FDA 510(k) clearance for the CATHETER INTRODUCER SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on March 6, 2014, 275 days after receiving the submission on June 4, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K131627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2013 |
| Decision Date | March 06, 2014 |
| Days to Decision | 275 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 |