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FDA 510(k)

KardiaPSI Balloon Catheter

K-Number: K253855 · 2026-05-06

ApplicantIntervention Tech, Inc. ; dba Corvention
Decision Date2026-05-06
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: OZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa MedinotecK240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K220881INOUE BALLOON AToray Industries, Inc.K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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