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510(k) K223077

ViewFlex Xtra ICE Catheter by Irvine Biomedical, A St. Jude Medical Company — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
September 30, 2022
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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