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510(k) K163542

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case by Datascope Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2017
Date Received
December 16, 2016
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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  • K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND A (December 12, 2013)
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  • K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 IN (January 5, 2007)
  • K062754 — GAS MODULE SE, MODEL 0998-00-0481-02 (November 2, 2006)

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