K213915 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 January 12, 2022, 28 days after receiving the submission on December 15, 2021.
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 | K213915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2021 |
| Decision Date | January 12, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |