Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) 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. The listed applicant is Arrow International, Inc.. The 510(k) number is K200634.

When did Arrow FiberOptix Intra-Aortic Balloon Catheter Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Arrow FiberOptix Intra-Aortic Balloon Catheter Kit?

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

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

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_RECRUITING

Other records listing Arrow International, Inc. 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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpK232343AC3™ Series IABPK222341Arrow 0.2 Micron Flat Filter, GVSK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPK190101UltraFlex 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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow 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.

↑