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510(k) K250552

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire by Abbott Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2025
Date Received
February 25, 2025
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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