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510(k) K242420

pNOVUS 21 Microcatheter by Phenox, Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2024
Date Received
August 15, 2024
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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