FDA 510(k)

KardiaPSI Balloon Catheter

N.º K: K253855 · 2026-05-06

SolicitanteIntervention Tech, Inc. ; dba Corvention

Fecha de decisión2026-05-06

Código de productoOZT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

KardiaPSI Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Intervention Tech, Inc. ; dba Corvention. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K253855. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KardiaPSI Balloon Catheter?

KardiaPSI Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Intervention Tech, Inc. ; dba Corvention. The 510(k) number is K253855.

When did KardiaPSI Balloon Catheter receive FDA 510(k) clearance?

KardiaPSI Balloon Catheter received FDA 510(k) clearance on 2026-05-06, under 510(k) number K253855.

Who is the listed applicant for KardiaPSI Balloon Catheter?

The FDA 510(k) record lists Intervention Tech, Inc. ; dba Corvention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KardiaPSI Balloon Catheter?

The FDA product code for KardiaPSI Balloon Catheter is OZT.

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Fuente oficial

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