Name: Predicase
Price: 199 USD

K-number	K253399
Device name	Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
Applicant	Volcano Corporation (Dba Philips Image Guided Therapy Device
Product code	OBJ
Device class	Class II
Decision date	Oct 28, 2025
Decision	Substantially Equivalent
Regulation	870.1200

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.