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)

Fiberoptix IAB

K-Number: K190117 · 2019-06-13

ApplicantArrow International, Inc.
Decision Date2019-06-13
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fiberoptix IAB 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 2019-06-13 under 510(k) 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. The listed applicant is Arrow International, Inc.. The 510(k) number is K190117.

When did Fiberoptix IAB receive FDA 510(k) clearance?

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

Who is the listed applicant for Fiberoptix IAB?

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 Fiberoptix IAB?

The FDA product code for Fiberoptix IAB is DSP.

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 IABPK200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitK190101UltraFlex 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.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex 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.

↑