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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K172394
Device Name Steerable Guide Catheter
Applicant
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact Makena Mc Gowan
Correspondent
Abbott Vascular
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact Makena Mc Gowan
Regulation Number870.1280
Classification Product Code
DRA  
Date Received08/08/2017
Decision Date 09/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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