← Product Code [DXF](/productcode/DXF) · K261745

# LightningWire Transseptal Puncture System (TPS) (K261745)

_ElectroWire Medical · DXF · Jun 26, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261745

## Device Facts

- **Applicant:** ElectroWire Medical
- **Product Code:** [DXF](/productcode/DXF.md)
- **Decision Date:** Jun 26, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5175
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** 3rd-Party Reviewed

## 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/device/K261745](https://fda.innolitics.com/device/K261745)

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