K955413 is an FDA 510(k) clearance for the ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE).
Submitted by Endovations (Reading, US). The FDA issued a Cleared decision on February 8, 1996, 73 days after receiving the submission on November 27, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K955413 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 27, 1995 |
| Decision Date | February 08, 1996 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |