K080332 is an FDA 510(k) clearance for the POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on September 5, 2008, 211 days after receiving the submission on February 7, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K080332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2008 |
| Decision Date | September 05, 2008 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW — Prosthesis, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |