Cleared Traditional

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

K160583 · Volcano Corporation · Cardiovascular
Oct 2016
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K160583 is an FDA 510(k) clearance for the REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip, 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 October 26, 2016, 239 days after receiving the submission on March 1, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K160583 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2016
Decision Date October 26, 2016
Days to Decision 239 days
Submission Type Traditional
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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