FDA 510(k)

UltraFlex IAB

K-Number: K190101 · 2019-06-28

Decision Date2019-06-28

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

UltraFlex IAB is a medical device manufactured by Arrow International, Inc.. It received FDA 510(k) clearance on 2019-06-28 under approval number K190101. 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 UltraFlex IAB?

UltraFlex IAB is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Arrow International, Inc.. The 510(k) number is K190101.

When was UltraFlex IAB approved by the FDA?

UltraFlex IAB received FDA 510(k) clearance on 2019-06-28, under approval number K190101.

What company makes UltraFlex IAB?

UltraFlex IAB is manufactured by Arrow International, Inc..

What is the FDA product code for UltraFlex IAB?

The FDA product code for UltraFlex IAB is DSP.

Other Devices by Arrow International, Inc.

K162820AC3 Series IABP System 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. 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 K190117Fiberoptix 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.