510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVMClass II

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

21 CFR 870.1250 / Cardiovascular
FDA source (opens on fda.gov)

NVM is the FDA product code for Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NVM
Device name
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
FDA definition
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
2

Clearances, product code NVM

By decision year
5 clearances under product code NVM with a decision year between 2005 and 2022, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NVM by decision year
YearClearances
20051
20162
20211
20221

Applicants with the most clearances

Product code NVM
Applicants holding the most 510(k) clearances under product code NVM
ApplicantClearances
Numed Inc5

Companies listing this code with FDA

Companies whose registered establishments list this code