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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 K212026
Device Name Amplatzer Steerable Delivery Sheath
Applicant
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Applicant Contact Dan Gapp
Correspondent
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Correspondent Contact Dan Gapp
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/29/2021
Decision Date 09/27/2021
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
Recalls CDRH Recalls
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