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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon Aortic Valvuloplasty
510(k) Number K253855
Device Name KardiaPSI Balloon Catheter
Applicant
Intervention Tech, Inc. ; dba Corvention
2201 N. Gemini Dr.
Suite 132
Flagstaff,  AZ  86001
Applicant Contact Ryan Smith
Correspondent
Ikigai Medical Development
2198 Zinnia Way
Golden,  CO  80401
Correspondent Contact Natasha Bond
Regulation Number870.1255
Classification Product Code
OZT  
Date Received12/03/2025
Decision Date 05/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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