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) → OMZ — Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

# OMZ · Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

_Cardiovascular · 21 CFR 870.1250 · Class 2_

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

## Overview

- **Product Code:** OMZ
- **Device Name:** Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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 |
| --- | --- | --- | --- | --- |
| [K153069](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OMZ/K153069.md) | Edwards Balloon Catheter | Edwards Lifesciences | Jan 7, 2016 | SESE |
| [K131002](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OMZ/K131002.md) | VIDA PTV DILATATON CATHETER | C.R. Bard, Inc. | Jul 2, 2013 | SESE |
| [K122367](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OMZ/K122367.md) | BARD PTV DILATATION CATHETER | C.R. Bard, Inc. | Nov 2, 2012 | SESE |
| [K102473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OMZ/K102473.md) | MULLINS-X PTV CATHETER | NuMED, Inc. | Dec 9, 2010 | SESE |
| [K014124](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OMZ/K014124.md) | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | Jan 16, 2002 | SESE |

## Top Applicants

- C.R. Bard, Inc. — 2 clearances
- NuMED, Inc. — 2 clearances
- Edwards Lifesciences — 1 clearance

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

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