FDA 510(k)

KardiaPSI Balloon Catheter

Номер K: K253855 · 2026-05-06

ЗаявительIntervention Tech, Inc. ; dba Corvention

Дата решения2026-05-06

Код продуктаOZT

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OZT)

K260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec K240967ValvuloPro 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.

Официальный источник

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