← Product Code [DXF](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF) · K011557

# PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K011557)

_NuMED, Inc. · DXF · Jul 12, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K011557

## Device Facts

- **Applicant:** NuMED, Inc.
- **Product Code:** [DXF](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF.md)
- **Decision Date:** Jul 12, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.5175
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K011557](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K011557)

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