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FDA 510(k)

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

K-Number: K200634 · 2020-04-09

ApplicantArrow International, Inc.
Decision Date2020-04-09
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit is a medical device manufactured by Arrow International, Inc.. It received FDA 510(k) clearance on 2020-04-09 under approval number K200634. 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 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit?

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Arrow International, Inc.. The 510(k) number is K200634.

When was Arrow FiberOptix Intra-Aortic Balloon Catheter Kit approved by the FDA?

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit received FDA 510(k) clearance on 2020-04-09, under approval number K200634.

What company makes Arrow FiberOptix Intra-Aortic Balloon Catheter Kit?

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit is manufactured by Arrow International, Inc..

What is the FDA product code for Arrow FiberOptix Intra-Aortic Balloon Catheter Kit?

The FDA product code for Arrow FiberOptix Intra-Aortic Balloon Catheter Kit 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 NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_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, Inc.

K162820AC3 Series IABP System K190101UltraFlex IAB K190117Fiberoptix IAB K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

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

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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