Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5175](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5175) → QLZ — Septostomy Catheter, Reprocessed

# QLZ · Septostomy Catheter, Reprocessed

_Cardiovascular · 21 CFR 870.5175 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QLZ

## Overview

- **Product Code:** QLZ
- **Device Name:** Septostomy Catheter, Reprocessed
- **Regulation:** [21 CFR 870.5175](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5175)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **GMP exempt:** yes

## Identification

A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K213584](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QLZ/K213584.md) | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | Apr 4, 2023 | SESE |
| [K200060](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QLZ/K200060.md) | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | Jul 30, 2020 | SESE |

## Top Applicants

- Innovative Health, LLC — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QLZ](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QLZ)

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