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510(k) K201112

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP by Arrow International, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2020
Date Received
April 27, 2020
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 Arrow International, Inc.

  • K250542 — AC3™ Range™ Intra-Aortic Balloon Pump (March 26, 2025)
  • K232343 — AC3™ Series IABP (August 30, 2023)
  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 9, 2020)
  • K190101 — UltraFlex IAB (June 28, 2019)
  • K190117 — Fiberoptix IAB (June 13, 2019)
  • K162820 — AC3 Series IABP System (March 31, 2017)
  • K141051 — VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIAL (July 7, 2014)
  • K130192 — NEXTSTEP RETROGRADE (May 10, 2013)
  • K130876 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET (April 26, 2013)

Other clearances for product code DSP

  • K250542 — AC3™ Range™ Intra-Aortic Balloon Pump (March 26, 2025)
  • K232343 — AC3™ Series IABP (August 30, 2023)
  • 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)
  • K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Batter (January 31, 2017)