Cleared Special

Visions PV .035 Digital IVUS Catheter

K153094 · Volcano Corporation · Cardiovascular
Dec 2015
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K153094 is an FDA 510(k) clearance for the Visions PV .035 Digital IVUS Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on December 31, 2015, 66 days after receiving the submission on October 26, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K153094 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2015
Decision Date December 31, 2015
Days to Decision 66 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.

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