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
Cleared
Sep 22, 2016
BIB Stent Placement Catheter
NuMED, Inc.
Cardiovascular
119d
Cleared
May 20, 2016
BIB Stent Placement Catheter
NuMED, Inc.
Cardiovascular
50d
Cleared
Jul 28, 2005
BIB PTA BALLOON CATHETER
NuMED, Inc.
Cardiovascular
114d
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.