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510(k) K031636

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX by Datascope Corp. — Product Code DSP

K031636 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX". The FDA issued a decision of Substantially Equivalent on August 11, 2003. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Datascope Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2003
Date Received
May 27, 2003
Clearance Type
Abbreviated
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

Other clearances by Datascope Corp.

  • K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (December 26, 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)
  • K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Batter (January 31, 2017)
  • K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (July 2, 2015)
  • K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND A (December 12, 2013)
  • K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (September 25, 2007)
  • K062569 — SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (February 14, 2007)
  • K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (February 5, 2007)
  • K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 IN (January 5, 2007)

Other clearances for product code DSP

  • K250542 — AC3™ Range™ Intra-Aortic Balloon Pump (March 26, 2025)
  • K232343 — AC3™ Series IABP (August 30, 2023)
  • K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (May 27, 2020)
  • 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)

FDA data resources