K896203 is an FDA 510(k) clearance for the SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER. This device is classified as a Microfilter, Blood Transfusion (Class II - Special Controls, product code CAK).
Submitted by Solco Basle, Inc. (Hingham, US). The FDA issued a Cleared decision on February 1, 1990, 98 days after receiving the submission on October 26, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K896203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1989 |
| Decision Date | February 01, 1990 |
| Days to Decision | 98 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 |