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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 K232690
Device Name Amulet™ Steerable Delivery Sheath
Applicant
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Applicant Contact Dan Gapp
Correspondent
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Correspondent Contact Dan Gapp
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/01/2023
Decision Date 09/29/2023
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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