LightningWire Transseptal Puncture System (TPS)
Device Facts
| Record ID | K261745 |
|---|---|
| Device Name | LightningWire Transseptal Puncture System (TPS) |
| Applicant | ElectroWire Medical |
| Product Code | DXF · Cardiovascular |
| Decision Date | Jun 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5175 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
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.
