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FDA 510(k)

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

K-Number: K201112 · 2020-05-27

ApplicantArrow International, Inc.
Decision Date2020-05-27
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is a medical device manufactured by Arrow International, Inc.. It received FDA 510(k) clearance on 2020-05-27 under approval number K201112. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is a medical device that received FDA 510(k) clearance on 2020-05-27. It is manufactured by Arrow International, Inc.. The 510(k) number is K201112.

When was AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP approved by the FDA?

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP received FDA 510(k) clearance on 2020-05-27, under approval number K201112.

What company makes AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is manufactured by Arrow International, Inc..

What is the FDA product code for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

The FDA product code for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is DSP.

Other Devices by Arrow International, Inc.

K162820AC3 Series IABP System K190101UltraFlex IAB K190117Fiberoptix IAB K200634Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

Related Devices (Code: DSP)

K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. K162820AC3 Series IABP SystemArrow International, Inc. K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex K190101UltraFlex IABArrow International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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