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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 K260499
Device Name Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
Applicant
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Applicant Contact Meghann Kayoum
Correspondent
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Correspondent Contact Meghann Kayoum
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/13/2026
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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