K253855
- 510(k) number
- K253855
- Device name
- KardiaPSI Balloon Catheter
- Applicant
- Intervention Tech, Inc. ; dba Corvention AZ · US
- Product code
- OZT — Balloon Aortic Valvuloplasty
- Decision date
- 2026-05-06
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253855.pdf
Official FDA record: K253855
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.