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510(k) K213593

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD by Boston Scientific Corporation — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2022
Date Received
November 12, 2021
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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