Product code NVM— Cardiovascular

BIB Stent Placement Catheter

Classification name: Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Total cleared: 5
First cleared: 2005-07-28
Most recent: 2022-01-12

FDA classification definition

“Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries”
— U.S. Food and Drug Administration, device classification record for product code NVM under 21 CFR 870.1250, via openFDA

Market context for product code NVM

FDA has cleared 5 devices under product code NVM between 2005 and 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20221 clearance
20211 clearance
20162 clearances
20051 clearance

Top applicants under product code NVM

NuMED, Inc.5 clearances

Recent clearances under product code NVM

K213915 — BIB Stent Placement CatheterNuMED, Inc.·2022-01-12
K211134 — BIB Stent Placement CatheterNuMED, Inc.·2021-05-27
K161451 — BIB Stent Placement CatheterNuMED, Inc.·2016-09-22
K160889 — BIB Stent Placement CatheterNuMED, Inc.·2016-05-20
K050857 — BIB PTA BALLOON CATHETERNuMED, Inc.·2005-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.