K060519 is an FDA 510(k) clearance for the INTRODUCER ASSEMBLY WITH ROTATOR LOCK. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on May 5, 2006, 67 days after receiving the submission on February 27, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K060519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2006 |
| Decision Date | May 05, 2006 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |