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510(k) K200144

HI-TORQUE Steelcore Bare Guide Wire by Abbott Vascular — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2020
Date Received
January 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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