Home / 510(k) Clearances / K172455

510(k) K172455

CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit by Volcano Corporation — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2017
Date Received
August 14, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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