K955485 is an FDA 510(k) clearance for the BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by B.Braun Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 23, 1996, 84 days after receiving the submission on December 1, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K955485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1995 |
| Decision Date | February 23, 1996 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |