Home / 510(k) Clearances / K120868

510(k) K120868

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER by Datascope Corp., Cardiac Assist Division — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2012
Date Received
March 22, 2012
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

Other clearances by Datascope Corp., Cardiac Assist Division

  • K122405 — AIR-BAND RADIAL COMPRESSION DEVICE (November 9, 2012)
  • K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES (September 6, 2012)
  • K091449 — DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684 (June 18, 2009)

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)