K124046 is an FDA 510(k) clearance for the VALVED TEARAWAY INTRODUCER GENERATION II. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 3, 2013, 154 days after receiving the submission on December 31, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K124046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2012 |
| Decision Date | June 03, 2013 |
| Days to Decision | 154 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 |