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FDA 510(k) Application Details - K181122
Device Classification Name
System, Balloon, Intra-Aortic And Control
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510(K) Number
K181122
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
Datascope Corp.
1300 MacArthur Blvd.
Mahwah, NJ 07430 US
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Contact
Hemang Kotecha
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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
04/30/2018
Decision Date
05/31/2018
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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