FDA product code NVM: Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
NVM is the FDA product code for catheter, angioplasty, peripheral, transluminal, dual-balloon. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under NVM, 1 in the last five years. The average 510(k) review took 70 days (median 50). FDA has posted 2 recalls for NVM devices, 1 initiated in the last five years.
Definition
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NVM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 41 |
| 2022 | 1 | 28 |
Compare with all 510(k) review times · Search every NVM clearance
Top NVM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| NuMED, Inc. | 5 | 2022-01-12 |
Most recent NVM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213915 | NuMED, Inc. | BIB Stent Placement Catheter | 2022-01-12 | 28 |
| K211134 | NuMED, Inc. | BIB Stent Placement Catheter | 2021-05-27 | 41 |
| K161451 | NuMED, Inc. | BIB Stent Placement Catheter | 2016-09-22 | 119 |
| K160889 | NuMED, Inc. | BIB Stent Placement Catheter | 2016-05-20 | 50 |
| K050857 | NuMED, Inc. | BIB PTA BALLOON CATHETER | 2005-07-28 | 114 |
Recalls for NVM devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2025-04-21.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code NVM?
NVM is the FDA product code for catheter, angioplasty, peripheral, transluminal, dual-balloon. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is NVM?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVM?
Across 5 cleared submissions the average was 70 days from receipt to decision (median 50).
Which companies have the most NVM clearances?
NuMED, Inc. (5).
Have NVM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NVM
- Run a recall and safety report across every NVM manufacturer
- Watch product code NVM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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