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FDA 510(k)

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

K-Number: K253399 · 2025-10-28

ApplicantVolcano Corporation (Dba Philips Image Guided Therapy Device
Decision Date2025-10-28
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Volcano Corporation (Dba Philips Image Guided Therapy Device. The 510(k) number is K253399.

When was Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter approved by the FDA?

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

What company makes 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 manufactured by Volcano Corporation (Dba Philips Image Guided Therapy Device.

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.

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

Official Source

View on FDA Database →

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

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