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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 K190167
Device Name MitraClip G4 Steerable Guide Catheter
Applicant
Abbott
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact Ekta Lad
Correspondent
Abbott
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact Ekta Lad
Regulation Number870.1280
Classification Product Code
DRA  
Date Received01/31/2019
Decision Date 05/29/2019
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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