FDA Product Code NVM: Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries
Leading manufacturers include NuMED, Inc..
5
Total
5
Cleared
70d
Avg days
2005
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon Devices (Product Code NVM)
5 devices
Cleared
Jan 12, 2022
BIB Stent Placement Catheter
NuMED, Inc.
Cardiovascular
28d
Cleared
May 27, 2021
BIB Stent Placement Catheter
NuMED, Inc.
Cardiovascular
41d
About Product Code NVM - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code NVM since 2005, with 5 receiving FDA clearance (average review time: 70 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
NVM devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →