FDA 510(k)

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Номер K: K243184 · 2025-06-25

ЗаявительStrait Access Technologies Holdings

Дата решения2025-06-25

Код продуктаDQY

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

SAT CenterFlow Molding Balloon Catheter (IN20-00313) is the device name listed in this FDA 510(k) record. The listed applicant is Strait Access Technologies Holdings. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K243184. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

SAT CenterFlow Molding Balloon Catheter (IN20-00313) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Strait Access Technologies Holdings. The 510(k) number is K243184.

When did SAT CenterFlow Molding Balloon Catheter (IN20-00313) receive FDA 510(k) clearance?

SAT CenterFlow Molding Balloon Catheter (IN20-00313) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K243184.

Who is the listed applicant for SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

The FDA 510(k) record lists Strait Access Technologies Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAT CenterFlow Molding Balloon Catheter (IN20-00313)?

The FDA product code for SAT CenterFlow Molding Balloon Catheter (IN20-00313) is DQY.

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: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Доставочный катетерCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Доставка Система; Amplatzer TorqVue LP КатетерAbbott

Официальный источник

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