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510(k) K232573

INFINITI™ Ambi Angiographic Catheter by Cordis US Corp — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
August 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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