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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K222113
Device Name Abiomed 14Fr Low Profile Introducer Set
Applicant
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact Ken Ryder
Correspondent
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Ken Ryder
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/18/2022
Decision Date 10/13/2022
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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