K915482 is an FDA 510(k) clearance for the B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT. This device is classified as a Suction Control, Intracardiac, Cardiopulmonary Bypass (Class II - Special Controls, product code DWD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 7, 1992, 32 days after receiving the submission on December 6, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4430.
| 510(k) Number | K915482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1991 |
| Decision Date | January 07, 1992 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4430 |