K063658 is an FDA 510(k) clearance for the INTRAVASCULAR INTRODUCER SYSTEM. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on September 12, 2007, 278 days after receiving the submission on December 8, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K063658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2006 |
| Decision Date | September 12, 2007 |
| Days to Decision | 278 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 |