K161451 is an FDA 510(k) clearance for the BIB Stent Placement 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 September 22, 2016, 119 days after receiving the submission on May 26, 2016.
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 | K161451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2016 |
| Decision Date | September 22, 2016 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| 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 |