K931441 is an FDA 510(k) clearance for the FENWAL 40 MICRON TRANSFUSION FILTER. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 21, 1993, 183 days after receiving the submission on March 22, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K931441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1993 |
| Decision Date | September 21, 1993 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |