FDA 510(k)

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

Numéro K : K253399 · 2025-10-28

DemandeurVolcano Corporation (Dba Philips Image Guided Therapy Device

Date de décision2025-10-28

Code produitOBJ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : OBJ)

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Source officielle

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