K955497 is an FDA 510(k) clearance for the GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by Cobe Renal Care, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 25, 1997, 664 days after receiving the submission on December 1, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K955497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1995 |
| Decision Date | September 25, 1997 |
| Days to Decision | 664 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDL — Set, Perfusion, Kidney, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |