Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

# NVM · Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

_Cardiovascular · 21 CFR 870.1250 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM

## Overview

- **Product Code:** NVM
- **Device Name:** Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K213915](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM/K213915.md) | BIB Stent Placement Catheter | NuMED, Inc. | Jan 12, 2022 | SESE |
| [K211134](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM/K211134.md) | BIB Stent Placement Catheter | NuMED, Inc. | May 27, 2021 | SESE |
| [K161451](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM/K161451.md) | BIB Stent Placement Catheter | NuMED, Inc. | Sep 22, 2016 | SESE |
| [K160889](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM/K160889.md) | BIB Stent Placement Catheter | NuMED, Inc. | May 20, 2016 | SESE |
| [K050857](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM/K050857.md) | BIB PTA BALLOON CATHETER | NuMED, Inc. | Jul 28, 2005 | SESU |

## Top Applicants

- NuMED, Inc. — 5 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NVM)

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