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FDA 510(k)

AC3 Series IABP System

K-Number: K162820 · 2017-03-31

ApplicantArrow International, Inc.
Decision Date2017-03-31
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC3 Series IABP System is a medical device manufactured by Arrow International, Inc.. It received FDA 510(k) clearance on 2017-03-31 under approval number K162820. 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 System?

AC3 Series IABP System is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Arrow International, Inc.. The 510(k) number is K162820.

When was AC3 Series IABP System approved by the FDA?

AC3 Series IABP System received FDA 510(k) clearance on 2017-03-31, under approval number K162820.

What company makes AC3 Series IABP System?

AC3 Series IABP System is manufactured by Arrow International, Inc..

What is the FDA product code for AC3 Series IABP System?

The FDA product code for AC3 Series IABP System is DSP.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Arrow International, Inc.

K190101UltraFlex IAB K190117Fiberoptix IAB K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP K200634Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

Related Devices (Code: DSP)

K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. 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. K190117Fiberoptix 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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