K914162 is an FDA 510(k) clearance for the VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS. This device is classified as a Catheter, Subclavian (Class II — Special Controls, product code LFJ).
Submitted by Vas-Cath, Inc. (Mississauga,Ontario, CA). The FDA issued a Cleared decision on July 1, 1993, 653 days after receiving the submission on September 17, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K914162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 17, 1991 |
| Decision Date | July 01, 1993 |
| Days to Decision | 653 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |