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510(k) K230453

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter by Boston Scientific Corporation — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2023
Date Received
February 21, 2023
Clearance Type
Special
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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