K945396 is an FDA 510(k) clearance for the FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by B.Braun Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 13, 1995, 130 days after receiving the submission on November 3, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K945396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1994 |
| Decision Date | March 13, 1995 |
| Days to Decision | 130 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 |