FDA 510(k)

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Номер K: K253399 · 2025-10-28

ЗаявительVolcano Corporation (Dba Philips Image Guided Therapy Device

Дата решения2025-10-28

Код продуктаOBJ

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation (Dba Philips Image Guided Therapy Device. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K253399. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter?

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Volcano Corporation (Dba Philips Image Guided Therapy Device. The 510(k) number is K253399.

When did Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter receive FDA 510(k) clearance?

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter received FDA 510(k) clearance on 2025-10-28, under 510(k) number K253399.

Who is the listed applicant for Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter?

The FDA 510(k) record lists Volcano Corporation (Dba Philips Image Guided Therapy Device as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter?

The FDA product code for Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter is OBJ.

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: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

Официальный источник

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