K013737 is an FDA 510(k) clearance for the MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on March 1, 2002, 108 days after receiving the submission on November 13, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K013737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2001 |
| Decision Date | March 01, 2002 |
| Days to Decision | 108 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |