K914882 is an FDA 510(k) clearance for the WILTEK BALLOON CHOLANGIOGRAPHY CATHETER, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 7, 1992, 69 days after receiving the submission on October 30, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K914882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 1991 |
| Decision Date | January 07, 1992 |
| Days to Decision | 69 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 |