FDA 510(k)

Fiberoptix IAB

K-Number: K190117 · 2019-06-13

Decision Date2019-06-13

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fiberoptix IAB is a medical device manufactured by Arrow International, Inc.. It received FDA 510(k) clearance on 2019-06-13 under approval number K190117. 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 Fiberoptix IAB?

Fiberoptix IAB is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Arrow International, Inc.. The 510(k) number is K190117.

When was Fiberoptix IAB approved by the FDA?

Fiberoptix IAB received FDA 510(k) clearance on 2019-06-13, under approval number K190117.

What company makes Fiberoptix IAB?

Fiberoptix IAB is manufactured by Arrow International, Inc..

What is the FDA product code for Fiberoptix IAB?

The FDA product code for Fiberoptix IAB is DSP.

Other Devices by Arrow International, Inc.

K162820AC3 Series IABP System K190101UltraFlex 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 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.