510(k) K240997

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
November 6, 2024
Date Received
April 11, 2024
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