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510(k) K182538

Merit RadialFlo Arterial Catheter by Merit Medical Singapore Pte. , Ltd. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2019
Date Received
September 14, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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