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FDA 510(k)

BioFlo Midline Catheter

K-Number: K161866 · 2016-09-08

ApplicantNavilyst Medical, Inc.
Decision Date2016-09-08
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BioFlo Midline Catheter is a medical device manufactured by Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval number K161866. 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 BioFlo Midline Catheter?

BioFlo Midline Catheter is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by Navilyst Medical, Inc.. The 510(k) number is K161866.

When was BioFlo Midline Catheter approved by the FDA?

BioFlo Midline Catheter received FDA 510(k) clearance on 2016-09-08, under approval number K161866.

What company makes BioFlo Midline Catheter?

BioFlo Midline Catheter is manufactured by Navilyst Medical, Inc..

What is the FDA product code for BioFlo Midline Catheter?

The FDA product code for BioFlo 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 NCT06979167 Complications of Midline Catheter in Surgical Children COMPLETED NCT06770374 Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients RECRUITING NCT06884176 CVCs Versus Midline Catheters NOT_YET_RECRUITING

Other Devices by Navilyst Medical, Inc.

K151239NMI DUAL PORT II K163452PICC Maximal Barrier Nursing Kit

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. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd. K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, 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.

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