510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253399Substantially Equivalent

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

Volcano Corporation (dba Philips Image Guided Therapy Device, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253399 is the FDA 510(k) clearance record for Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter, a class II device, cleared for Volcano Corporation (Dba Philips Image Guided Therapy Device on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list one 510(k) clearance for Volcano Corporation (Dba Philips Image Guided Therapy Device. As of , FDA records show no recalls naming K253399.

Clearance record

Decision date
Received
(28 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Volcano Corporation (Dba Philips Image Guided Therapy Device 3721 Valley Centre Dr., Suite 500, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBJ

Trailing 12 months
4 clearances under product code OBJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260