K851816 is an FDA 510(k) clearance for the SARTORIUS MINISART FH 16534. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Sartorius Filters, Inc. (Hayward, US). The FDA issued a Cleared decision on August 19, 1985, 115 days after receiving the submission on April 26, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K851816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1985 |
| Decision Date | August 19, 1985 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |