K933869 is an FDA 510(k) clearance for the EXTENSION SET WITH 0.22 MICRON 96 HOUR 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 April 26, 1994, 260 days after receiving the submission on August 9, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K933869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1993 |
| Decision Date | April 26, 1994 |
| Days to Decision | 260 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 |