Cleared Special

K152829 - Visions PV.014P RX Digital IVUS Catheter
(FDA 510(k) Clearance)

K152829 · Volcano Corporation · Cardiovascular

Nov 2015

Decision

51d

Days

Class 2

Risk

K152829 is an FDA 510(k) clearance for the Visions PV.014P RX 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 November 19, 2015, 51 days after receiving the submission on September 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K152829 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2015
Decision Date	November 19, 2015
Days to Decision	51 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.