NVM
5 FDA 510(k) clearances · Product code
50 daysmedian time to decision
119 days90th percentile
5clearances measured
FDA profile
- Official device name
- Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- FDA definition
- Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIB Stent Placement Catheter (K213915) | NuMED, Inc. | 2022-01-12 |
| BIB Stent Placement Catheter (K211134) | NuMED, Inc. | 2021-05-27 |
| BIB Stent Placement Catheter (K161451) | NuMED, Inc. | 2016-09-22 |
| BIB Stent Placement Catheter (K160889) | NuMED, Inc. | 2016-05-20 |
| BIB PTA BALLOON CATHETER (K050857) | NuMED, Inc. | 2005-07-28 |
Track NVM automatically
Every clearance here is in the API, with alerts when new ones post.