Cleared Special

CORE M2 Vascular System

K170385 · Volcano Corporation · Radiology
Apr 2017
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K170385 is an FDA 510(k) clearance for the CORE M2 Vascular System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on April 6, 2017, 57 days after receiving the submission on February 8, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K170385 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2017
Decision Date April 06, 2017
Days to Decision 57 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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