K890717 is an FDA 510(k) clearance for the MODIFICATION HEMOFILTRATION CATHETER HF-100. This device is classified as a Catheter, Femoral (Class II - Special Controls, product code LFK).
Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on April 5, 1989, 51 days after receiving the submission on February 13, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K890717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1989 |
| Decision Date | April 05, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LFK — Catheter, Femoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |