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510(k) K172305

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump by Datascope Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2017
Date Received
July 31, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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