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FDA 510(k)

AC3 Series Intra-Aortic Balloon Pump (IABP)

K-Number: K192238 · 2019-11-12

ApplicantArrow International, Teleflex
Decision Date2019-11-12
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device manufactured by Arrow International, Teleflex. It received FDA 510(k) clearance on 2019-11-12 under approval number K192238. 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 Intra-Aortic Balloon Pump (IABP)?

AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device that received FDA 510(k) clearance on 2019-11-12. It is manufactured by Arrow International, Teleflex. The 510(k) number is K192238.

When was AC3 Series Intra-Aortic Balloon Pump (IABP) approved by the FDA?

AC3 Series Intra-Aortic Balloon Pump (IABP) received FDA 510(k) clearance on 2019-11-12, under approval number K192238.

What company makes AC3 Series Intra-Aortic Balloon Pump (IABP)?

AC3 Series Intra-Aortic Balloon Pump (IABP) is manufactured by Arrow International, Teleflex.

What is the FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP)?

The FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP) 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 NCT07194265 A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System RECRUITING NCT07532317 Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis NOT_YET_RECRUITING NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING

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. 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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