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FDA 510(k)

Arrow Endurance Extended Dwell Peripheral Catheter System

K-Number: K163513 · 2017-02-24

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2017-02-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Arrow Endurance Extended Dwell Peripheral Catheter System is a medical device manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2017-02-24 under approval number K163513. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arrow Endurance Extended Dwell Peripheral Catheter System?

Arrow Endurance Extended Dwell Peripheral Catheter System is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K163513.

When was Arrow Endurance Extended Dwell Peripheral Catheter System approved by the FDA?

Arrow Endurance Extended Dwell Peripheral Catheter System received FDA 510(k) clearance on 2017-02-24, under approval number K163513.

What company makes Arrow Endurance Extended Dwell Peripheral Catheter System?

Arrow Endurance Extended Dwell Peripheral Catheter System is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.).

What is the FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System?

The FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System is FOZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED

Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology K160018Arrow Quickflash Arterial Catheterization Device K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC K180395EZ-IO Intraosseous Vascular Access System

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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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