K965167 is an FDA 510(k) clearance for the PERCUTANEOUS VENOUS INTRODUCER 10264. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 25, 1997, 213 days after receiving the submission on December 24, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K965167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1996 |
| Decision Date | July 25, 1997 |
| Days to Decision | 213 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 |