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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 K192238
Device Name AC3 Series Intra-Aortic Balloon Pump (IABP)
Applicant
Arrow International, Teleflex
16 Elizabeth Drive
chelmsford,  MA  01824
Applicant Contact deb fleetham
Correspondent
Arrow International, Teleflex
16 Elizabeth Drive
chelmsford,  MA  01824
Correspondent Contact deb fleetham
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/19/2019
Decision Date 11/12/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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