K962726 is an FDA 510(k) clearance for the BARD QUANTUM CVR. This device is classified as a Defoamer, Cardiopulmonary Bypass (Class II - Special Controls, product code DTP).
Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on October 30, 1996, 107 days after receiving the submission on July 15, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K962726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1996 |
| Decision Date | October 30, 1996 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |