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FDA 510(k) Application Details - K200634
Device Classification Name
System, Balloon, Intra-Aortic And Control
More FDA Info for this Device
510(K) Number
K200634
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
Arrow International Inc.
16 Elizabeth Drive
Chelmsford, MA 01824 US
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Contact
Apurva N. Gokhale
Other 510(k) Applications for this Contact
Regulation Number
870.3535
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Classification Product Code
DSP
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More FDA Info for this Product Code
Date Received
03/10/2020
Decision Date
04/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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