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510(k) K063525

DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM by Datascope Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2007
Date Received
November 22, 2006
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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  • K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (July 2, 2015)
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  • K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (September 25, 2007)
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  • K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (February 5, 2007)
  • K062754 — GAS MODULE SE, MODEL 0998-00-0481-02 (November 2, 2006)

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  • K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 9, 2020)
  • K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP) (November 12, 2019)
  • K190101 — UltraFlex IAB (June 28, 2019)
  • K190117 — Fiberoptix IAB (June 13, 2019)
  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K162820 — AC3 Series IABP System (March 31, 2017)