FDA 510(k)

AC3 Range Intra-Aortic Balloon Pump

K-Number: K250542 · 2025-03-26

Decision Date2025-03-26

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AC3 Range Intra-Aortic Balloon Pump is a medical device manufactured by Arrow International, LLC. It received FDA 510(k) clearance on 2025-03-26 under approval number K250542. 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 Range Intra-Aortic Balloon Pump?

AC3 Range Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2025-03-26. It is manufactured by Arrow International, LLC. The 510(k) number is K250542.

When was AC3 Range Intra-Aortic Balloon Pump approved by the FDA?

AC3 Range Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2025-03-26, under approval number K250542.

What company makes AC3 Range Intra-Aortic Balloon Pump?

AC3 Range Intra-Aortic Balloon Pump is manufactured by Arrow International, LLC.

What is the FDA product code for AC3 Range Intra-Aortic Balloon Pump?

The FDA product code for AC3 Range Intra-Aortic Balloon Pump is DSP.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT06861361 Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients RECRUITING NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING NCT07545369 ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves NOT_YET_RECRUITING NCT06816485 INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis RECRUITING

Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Arrow International, LLC

K232343AC3 Series IABP K222341Arrow 0.2 Micron Flat Filter, GVS

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.