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510(k) K160583

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip by Volcano Corporation — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2016
Date Received
March 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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