K820472 is an FDA 510(k) clearance for the WILLIAM HARVEY H-625 ARTERIAL FILTER. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982, 24 days after receiving the submission on February 19, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K820472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1982 |
| Decision Date | March 15, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4260 |