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FDA 510(k)

ACENT™ Central Venous Catheter

K-Number: K193158 · 2020-11-24

ApplicantGlobal Medikit Limited
Decision Date2020-11-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACENT™ Central Venous Catheter is a medical device manufactured by Global Medikit Limited. It received FDA 510(k) clearance on 2020-11-24 under approval number K193158. 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 ACENT™ Central Venous Catheter?

ACENT™ Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2020-11-24. It is manufactured by Global Medikit Limited. The 510(k) number is K193158.

When was ACENT™ Central Venous Catheter approved by the FDA?

ACENT™ Central Venous Catheter received FDA 510(k) clearance on 2020-11-24, under approval number K193158.

What company makes ACENT™ Central Venous Catheter?

ACENT™ Central Venous Catheter is manufactured by Global Medikit Limited.

What is the FDA product code for ACENT™ Central Venous Catheter?

The FDA product code for ACENT™ Central Venous Catheter is FOZ.

Related Clinical Trials

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Other Devices by Global Medikit Limited

K212982Medispine - Spinal Needle, Glospine - Spinal Needle

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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