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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 K252766
Device Name 14Fr Low Profile Introducer Kit
Applicant
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact Anshul Shah
Correspondent
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Anshul Shah
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/29/2025
Decision Date 10/08/2025
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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