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Versacath(Tm) Selectalumen(Tm) W/Conversion Tray

by Menlo Care, Inc. 510(k)

Active United States

510(k) K910565

Overview

The Versacath Selectalumen with Conversion Tray is a catheter, intravascular, therapeutic, short-term (less than 30 days) designed for vascular access procedures. It is intended for temporary use in administering fluids, medications, or monitoring central venous pressure. The device falls under product code FOZ and is classified as Class II under FDA special controls, ensuring compliance with regulatory standards for short-term intravascular catheters.

This device is supplied as a sterile, single-use system and includes a conversion tray for easy handling and setup. It is intended for use in hospital settings, such as general medical wards, where short-term vascular access is required. The tray facilitates the sterile preparation and connection of the catheter to infusion lines or monitoring equipment. No additional regulatory markings beyond the FDA 510(k) clearance (K910565) are specified in the device data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SEKD Traditional NumberK910565 Date3 Jun 1991ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SEKD

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Questions

  • What is the Versacath Selectalumen with Conversion Tray used for?

    This device is designed for short-term (less than 30 days) vascular access in hospital settings like general medical wards. It allows for the administration of fluids or medications, as well as monitoring of central venous pressure. The conversion tray included simplifies setup by enabling sterile connection to infusion lines or monitoring equipment.

  • Is the Versacath Selectalumen with Conversion Tray sterile and single-use?

    Yes, the device is supplied as a sterile, single-use system. This ensures patient safety by preventing cross-contamination and reduces the risk of infection associated with reuse.

  • How does the conversion tray benefit clinical workflow?

    The conversion tray streamlines the preparation process by providing a sterile workspace. It allows clinicians to easily connect the catheter to infusion lines or monitoring equipment without compromising sterility, which is critical for minimizing infection risks during vascular access procedures.

  • What regulatory approval does this catheter hold?

    The Versacath Selectalumen with Conversion Tray holds FDA 510(k) clearance (K910565), meeting Class II regulatory standards for short-term intravascular catheters. This clearance ensures compliance with special controls for devices classified under product code FOZ.

  • Can this catheter be used for long-term vascular access?

    No, this catheter is specifically designed for short-term use only, intended for procedures lasting less than 30 days. For extended vascular access needs, alternative devices would be required to avoid complications like thrombosis or infection.