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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K241259
Device Name Amplatz Goose Neck Snare Kit
Applicant
Medtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis,  MN  55432
Applicant Contact Erin Roquemore
Correspondent
Medtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis,  MN  55432
Correspondent Contact Erin Roquemore
Regulation Number870.5150
Classification Product Code
MMX  
Subsequent Product Code
DXE  
Date Received05/06/2024
Decision Date 06/03/2024
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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