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FDA 510(k)

AC3™ Range™ Intra-Aortic Balloon Pump

K-Number: K250542 · 2025-03-26

ApplicantArrow International, LLC
Decision Date2025-03-26
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC3™ Range™ Intra-Aortic Balloon Pump is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC. It received FDA 510(k) clearance on 2025-03-26 under 510(k) 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. The listed applicant is Arrow International, LLC. The 510(k) number is K250542.

When did AC3™ Range™ Intra-Aortic Balloon Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for AC3™ Range™ Intra-Aortic Balloon Pump?

The FDA 510(k) record lists Arrow International, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06336655Physiology of Unloading VA ECMO TrialRECRUITINGNCT06049654Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve IndicationRECRUITINGNCT07761455Prophylactic IABP in Delayed-Presentation Anterior STEMINOT_YET_RECRUITINGNCT07794306Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic AnnuliNOT_YET_RECRUITING

Other records listing Arrow International, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232343AC3™ Series IABPK222341Arrow 0.2 Micron Flat Filter, GVSK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPK200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitK190101UltraFlex IABK190117Fiberoptix IAB

View all 8 devices →

Related Devices (Code: DSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex 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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