Panels › Cardiovascular › Product code NVM · Class 2
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Regulation 870.1250
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NVM
| Company | 510(k)s | Recalls |
|---|---|---|
| NuMED, Inc. | 5 | 1 |
| Arrow International Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2025 | Numed Inc BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Terminated |
NVM | K050857 |
| Oct 12, 2006 | Arrow International Inc Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart. Terminated |
NVM | None listed |
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