K261745
- 510(k) number
- K261745
- Device name
- LightningWire Transseptal Puncture System (TPS)
- Applicant
- ElectroWire Medical SC · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2026-06-26
- Date received
- 2026-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K261745.pdf
Official FDA record: K261745
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.