K253799
- 510(k) number
- K253799
- Device name
- SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- Applicant
- Pressure Products Medical Device Manufacturing, LLC PA · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2026-03-13
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253799.pdf
Official FDA record: K253799
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.