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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 K200144
Device Name HI-TORQUE Steelcore Bare Guide Wire
Applicant
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact Shilpa Satishchandra
Correspondent
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact Shilpa Satishchandra
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/22/2020
Decision Date 04/08/2020
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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