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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 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.

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. 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.

Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight 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 ScientificK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ABBOTT MEDICAL

Official Source

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