K051248 is an FDA 510(k) clearance for the VYGON MICRO-ACCESS SAFETY INTRODUCER KIT. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Vygon Corp. (Norristown, US). The FDA issued a Cleared decision on October 27, 2005, 164 days after receiving the submission on May 16, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K051248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2005 |
| Decision Date | October 27, 2005 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |