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510(k) K172258

Novasight Hybrid System by Conavi Medical, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2018
Date Received
July 26, 2017
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.

Other clearances by Conavi Medical, Inc.

  • K162789 — Foresight Intracardiac Echocardiology (ICE) System (March 28, 2017)

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