KardiaPSI Balloon Catheter
K-Number: K253855 · 2026-05-06
Decision Date2026-05-06
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaPSI Balloon Catheter is a medical device manufactured by Intervention Tech, Inc. ; dba Corvention. It received FDA 510(k) clearance on 2026-05-06 under approval number K253855. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KardiaPSI Balloon Catheter?
KardiaPSI Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-05-06. It is manufactured by Intervention Tech, Inc. ; dba Corvention. The 510(k) number is K253855.
When was KardiaPSI Balloon Catheter approved by the FDA?
KardiaPSI Balloon Catheter received FDA 510(k) clearance on 2026-05-06, under approval number K253855.
What company makes KardiaPSI Balloon Catheter?
KardiaPSI Balloon Catheter is manufactured by Intervention Tech, Inc. ; dba Corvention.
What is the FDA product code for KardiaPSI Balloon Catheter?
The FDA product code for KardiaPSI Balloon Catheter is OZT.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.