K914210 is an FDA 510(k) clearance for the VAS-CATH DUALATOR(TM) VESSEL DILATOR. This device is classified as a Dilator, Vessel (Class II - Special Controls, product code FKA).
Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on July 1, 1993, 651 days after receiving the submission on September 19, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K914210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1991 |
| Decision Date | July 01, 1993 |
| Days to Decision | 651 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FKA — Dilator, Vessel |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |