K932301 is an FDA 510(k) clearance for the FENWAL(R) 40/150 MICRON DUAL SCREEN 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 November 10, 1993, 182 days after receiving the submission on May 12, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K932301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1993 |
| Decision Date | November 10, 1993 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |