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Deseret Optima Intravascular Catheter

by Deseret Medical, Inc.

510(k) K900116

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900116 Date18 Jun 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Deseret Optima Intravascular Catheter is a catheter, intravascular, therapeutic, short-term (less than 30 days) as classified under FDA product code FOZ. Designed for temporary vascular access, it facilitates the administration of fluids, medications, or monitoring of hemodynamic parameters in clinical settings such as general hospitals. Its primary function aligns with short-duration therapeutic interventions requiring secure, low-profile lumen access.

This device is supplied as a single-use, sterile medical instrument, intended for aseptic insertion into peripheral or central veins. It adheres to FDA 510(k) clearance (K900116) under the General Hospital review panel, with a traditional clearance process. No additional regulatory markings (e.g., MRI safety, reusable status) are specified in the submission data. Storage and handling must comply with standard sterile medical device protocols to ensure integrity prior to use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Deseret Optima Intravascular Catheter used for?

    This catheter is designed for temporary vascular access in clinical settings, allowing healthcare providers to administer fluids or medications and monitor hemodynamic parameters. It is specifically classified for short-term use (less than 30 days) and is ideal for procedures requiring secure, low-profile lumen access without prolonged implantation.

  • Is the Deseret Optima Intravascular Catheter single-use or reusable?

    The Deseret Optima Intravascular Catheter is intended for single-use only. This design ensures sterility and reduces the risk of contamination or infection, which is critical for intravascular devices. Reuse is not recommended or supported by the manufacturer.

  • How should the Deseret Optima Intravascular Catheter be stored?

    The catheter must be stored according to standard sterile medical device protocols to maintain its integrity before use. This includes keeping it in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, until ready for aseptic insertion.

  • What regulatory clearance does the Deseret Optima Intravascular Catheter hold?

    The device holds FDA 510(k) clearance under the product code FOZ, classified as a therapeutic, short-term intravascular catheter. It was reviewed by the General Hospital Advisory Committee and granted traditional clearance with the K-number K900116, indicating it is deemed substantially equivalent to a predicate device.

  • Can this catheter be used for both peripheral and central vein access?

    Yes, the Deseret Optima Intravascular Catheter is designed for use in both peripheral and central veins. Its versatility makes it suitable for a range of short-term therapeutic interventions where secure vascular access is required, such as in general hospital settings.