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FDA 510(k)

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

K-Number: K223788 · 2023-09-15

ApplicantMedsource International, LLC
Decision Date2023-09-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is a medical device manufactured by Medsource International, LLC. It received FDA 510(k) clearance on 2023-09-15 under approval number K223788. 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 The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Medsource International, LLC. The 510(k) number is K223788.

When was The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter approved by the FDA?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter received FDA 510(k) clearance on 2023-09-15, under approval number K223788.

What company makes The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is manufactured by Medsource International, LLC.

What is the FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is FOZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 40261654 Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices. JAMA network open (2025) PMID: 32192636 Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist. Techniques in vascular and interventional radiology (2020) PMID: 31926779 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety. The Journal of emergency medicine (2020)

Other Devices by Medsource International, LLC

K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV 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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