K864235 is an FDA 510(k) clearance for the BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on January 2, 1987, 66 days after receiving the submission on October 28, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K864235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | January 02, 1987 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |