Cleared Special

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

K253399 · Volcano Corporation (Dba Philips Image Guided Therapy Device · Cardiovascular

Oct 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K253399 is an FDA 510(k) clearance for the Visions? PV .014P RX Digital IVUS Catheter ; Visions? PV .018 Digital IVUS Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Volcano Corporation (Dba Philips Image Guided Therapy Device (San Diego, US). The FDA issued a Cleared decision on October 28, 2025, 28 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K253399 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	October 28, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OBJ — Catheter, Ultrasound, Intravascular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1200
Definition	For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.