KardiaPSI Balloon Catheter— 510(k) K253855
Substantially EquivalentIntervention Tech, Inc. ; dba Corvention
FDA 510(k) clearance K253855 for KardiaPSI Balloon Catheter, Substantially Equivalent on 2026-05-06. Applicant: Intervention Tech, Inc. ; dba Corvention. Device class: 2.
Summary
The KardiaPSI Balloon Catheter comes from Intervention Tech, which the record lists as doing business as Corvention. It's filed under OZT, balloon aortic valvuloplasty.
Class II, 21 CFR 870.1255. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
The company filed from Flagstaff, Arizona. Review took 154 calendar days (December 3, 2025 to May 6, 2026).
Clearance details
- Applicant
- Intervention Tech, Inc. ; dba Corvention
- Product code
- Product code OZT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1255
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, US
Recent devices under product code OZT
view allAdverse events under product code OZT
product code OZT- Death
- 20
- Other
- 2
- Total
- 22
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.