FDA 510(k)

Perfect-O Ostial Positioning Catheter

Номер K: K260289 · 2026-06-05

Дата решения2026-06-05

Код продуктаDQY

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Perfect-O Ostial Positioning Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Balosmark, Inc.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260289. 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 Perfect-O Ostial Positioning Catheter?

Perfect-O Ostial Positioning Catheter is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Balosmark, Inc.. The 510(k) number is K260289.

When did Perfect-O Ostial Positioning Catheter receive FDA 510(k) clearance?

Perfect-O Ostial Positioning Catheter received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260289.

Who is the listed applicant for Perfect-O Ostial Positioning Catheter?

The FDA 510(k) record lists Balosmark, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfect-O Ostial Positioning Catheter?

The FDA product code for Perfect-O Ostial Positioning Catheter 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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