FDA 510(k)

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)

K-Number: K243599 · 2025-03-14

ApplicantArrow International, LLC (A subsidiary of Teleflex, Inc.)

Decision Date2025-03-14

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) is a medical device manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2025-03-14 under approval number K243599. 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 (EDC-00818)?

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K243599.

When was Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) approved by the FDA?

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) received FDA 510(k) clearance on 2025-03-14, under approval number K243599.

What company makes Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)?

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) is manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.).

What is the FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)?

The FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) 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, LLC (A subsidiary of Teleflex, Inc.)

K220280Arrow Stiffening Stylet K220363VPS Rhythm DLX Device with TipTracker Technology K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

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.