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FDA 510(k)

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

K-Number: K161779 · 2016-11-03

ApplicantMedsource International, LLC
Decision Date2016-11-03
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is a medical device manufactured by Medsource International, LLC. It received FDA 510(k) clearance on 2016-11-03 under approval number K161779. 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 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Medsource International, LLC. The 510(k) number is K161779.

When was MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter approved by the FDA?

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter received FDA 510(k) clearance on 2016-11-03, under approval number K161779.

What company makes MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is manufactured by Medsource International, LLC.

What is the FDA product code for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

The FDA product code for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is FOZ.

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Other Devices by Medsource International, LLC

K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. 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. 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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