K812874 is an FDA 510(k) clearance for the PEDIATRIC MICROAGGREGATE BLOOD FILTER. This device is classified as a Microfilter, Blood Transfusion (Class II - Special Controls, product code CAK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 2, 1981, 19 days after receiving the submission on October 14, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K812874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1981 |
| Decision Date | November 02, 1981 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | CAK — Microfilter, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |