FDA 510(k)

AC3 Series IABP

K-Number: K232343 · 2023-08-30

Decision Date2023-08-30

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AC3 Series IABP is a medical device manufactured by Arrow International, LLC. It received FDA 510(k) clearance on 2023-08-30 under approval number K232343. 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 Series IABP?

AC3 Series IABP is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Arrow International, LLC. The 510(k) number is K232343.

When was AC3 Series IABP approved by the FDA?

AC3 Series IABP received FDA 510(k) clearance on 2023-08-30, under approval number K232343.

What company makes AC3 Series IABP?

AC3 Series IABP is manufactured by Arrow International, LLC.

What is the FDA product code for AC3 Series IABP?

The FDA product code for AC3 Series IABP is DSP.

Other Devices by Arrow International, LLC

K222341Arrow 0.2 Micron Flat Filter, GVS K250542AC3 Range Intra-Aortic Balloon Pump

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

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