Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1350](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1350) → DQP — Kit, Balloon Repair, Catheter

# DQP · Kit, Balloon Repair, Catheter

_Cardiovascular · 21 CFR 870.1350 · Class 3_

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

## Overview

- **Product Code:** DQP
- **Device Name:** Kit, Balloon Repair, Catheter
- **Regulation:** [21 CFR 870.1350](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1350)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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