K821477 is an FDA 510(k) clearance for the WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 167 days after receiving the submission on May 18, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K821477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1982 |
| Decision Date | November 01, 1982 |
| Days to Decision | 167 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 |