K050857 is an FDA 510(k) clearance for the BIB PTA BALLOON CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon (Class II - Special Controls, product code NVM).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on July 28, 2005, 114 days after receiving the submission on April 5, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries.
| 510(k) Number | K050857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | April 05, 2005 |
| Decision Date | July 28, 2005 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries |