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TrueSafe Safety IV Catheter, TrueSafe Comfort Safety IV Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161779

by Medsource International Llc

Identifiers

510(k) Number
K161779 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TrueSafe Safety IV Catheter and TrueSafe Comfort Safety IV Catheter are intravascular catheters designed for peripheral venous access. These devices feature a needle retraction mechanism to reduce the risk of accidental needlesticks during insertion and removal, while maintaining standard intravenous catheter functionality. The TrueSafe Comfort variant incorporates VenaPUR® catheter material, which is intended to remain flexible and kink-resistant for improved patient comfort and ease of use.

These catheters are supplied as single-use, sterile devices intended for use in general hospital settings. They are available in various gauges, including a 26G option for neonatal applications, and are regulated under FDA 510(k) clearance (K161779) as substantially equivalent to predicate devices. Storage and handling follow standard sterile medical device protocols, with no specific MRI safety considerations noted. The product code FOZ categorizes them within the regulatory framework.

Frequently asked questions

What is the TrueSafe Safety IV Catheter designed for?

The TrueSafe Safety IV Catheter is designed for peripheral venous access in hospital settings. It features a needle retraction mechanism to minimize the risk of accidental needlesticks during insertion and removal, while maintaining standard intravenous catheter functionality. The TrueSafe Comfort variant includes VenaPUR® material for added flexibility and kink resistance, improving patient comfort.

How is the TrueSafe Safety IV Catheter supplied, and is it reusable?

The TrueSafe Safety IV Catheter is supplied as a single-use, sterile device. It is intended for one-time use only to ensure patient safety and prevent cross-contamination. Reuse is not recommended or approved for this product.

What gauges are available for the TrueSafe Safety IV Catheter, including neonatal options?

The TrueSafe Safety IV Catheter is available in multiple gauges, including a 26G option specifically designed for neonatal applications. This ensures compatibility with smaller veins commonly found in infants and young children.

How should the TrueSafe Safety IV Catheter be stored?

The TrueSafe Safety IV Catheter should be stored following standard sterile medical device protocols. This includes keeping it in its original packaging until ready for use, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

Are there any special considerations for MRI safety with this catheter?

No specific MRI safety considerations have been noted for the TrueSafe Safety IV Catheter. However, as with all medical devices, it is always advisable to consult the manufacturer’s instructions for use and any relevant clinical guidelines before use in an MRI environment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TrueSafe® Safety IV Catheters - Medsource Labs, TrueSafe® Family - Medsource Labs, TrueSafe Safety IV Catheters | Medline Industries, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medsource International Llc
FDA Applicant
Medsource International, LLC

Sources (1)

  • FDA 510(k) K161779 24 fields · synced Oct 1, 2026