K933294 is an FDA 510(k) clearance for the MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 9, 1994, 217 days after receiving the submission on July 7, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K933294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1993 |
| Decision Date | February 09, 1994 |
| Days to Decision | 217 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 |