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FDA 510(k)

Health Line CT Midline Catheter

K-Number: K200263 · 2020-03-12

ApplicantHealth Line International Corporation
Decision Date2020-03-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Health Line CT Midline Catheter is a medical device manufactured by Health Line International Corporation. It received FDA 510(k) clearance on 2020-03-12 under approval number K200263. 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 Health Line CT Midline Catheter?

Health Line CT Midline Catheter is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by Health Line International Corporation. The 510(k) number is K200263.

When was Health Line CT Midline Catheter approved by the FDA?

Health Line CT Midline Catheter received FDA 510(k) clearance on 2020-03-12, under approval number K200263.

What company makes Health Line CT Midline Catheter?

Health Line CT Midline Catheter is manufactured by Health Line International Corporation.

What is the FDA product code for Health Line CT Midline Catheter?

The FDA product code for Health Line CT Midline Catheter is FOZ.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT07361653 The REVIVE Pivotal Study NOT_YET_RECRUITING

Other Devices by Health Line International Corporation

K160448ARTLINE K192533Health Line CT CVC K200426Acute Dual Lumen Hemodialysis Catheter K222170Power Acute Triple Lumen Hemodialysis Catheter

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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