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510(k) K253399

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter by Volcano Corporation (Dba Philips Image Guided Therapy Device — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2025
Date Received
September 30, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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