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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K240997
Device Name Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
Applicant
ABBOTT MEDICAL
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact Angeline Chooi
Correspondent
ABBOTT MEDICAL
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact Angeline Chooi
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/11/2024
Decision Date 11/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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