K914936 is an FDA 510(k) clearance for the CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET. This device is classified as a Catheter, Femoral (Class II - Special Controls, product code LFK).
Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on April 23, 1992, 171 days after receiving the submission on November 4, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K914936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 04, 1991 |
| Decision Date | April 23, 1992 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFK — Catheter, Femoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |