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510(k) K191687

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire by Phenox Limited — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2019
Date Received
June 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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