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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K190581
Device Name Amplatzer Trevisio Intravascular Delivery System
Applicant
ABBOTT MEDICAL
5050 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact Mary Johnson
Correspondent
ABBOTT MEDICAL
5050 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact Mary Johnson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/06/2019
Decision Date 04/05/2019
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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