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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K232343
Device Name AC3™ Series IABP
Applicant
Arrow International, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Sheila Payzant
Correspondent
Arrow International, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Sheila Payzant
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/04/2023
Decision Date 08/30/2023
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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