K990514 is an FDA 510(k) clearance for the MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR. 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 March 9, 1999, 19 days after receiving the submission on February 18, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K990514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1999 |
| Decision Date | March 09, 1999 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |