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510(k) K221279

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2022
Date Received
May 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Phenox, Ltd.

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