NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon Class II

FDA Device Classification

Classification Details

Product Code
NVM
Device Class
Class II
Regulation Number
870.1250
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213915numedBIB Stent Placement CatheterJanuary 12, 2022
K211134numedBIB Stent Placement CatheterMay 27, 2021
K161451numedBIB Stent Placement CatheterSeptember 22, 2016
K160889numedBIB Stent Placement CatheterMay 20, 2016
K050857numedBIB PTA BALLOON CATHETERJuly 28, 2005