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Truject

by Clive Craig Co.

510(k) K945284

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 NumberK945284 Date29 Dec 1994ClearedStatusActive

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Truject is a Femoral Microcatheter (FMI), a small-diameter catheter designed for precise vascular access and intervention in peripheral arteries. It facilitates the delivery of contrast agents, guidewires, or therapeutic devices to target sites with minimal trauma, supporting diagnostic and interventional radiology procedures.

Supplied as a single-use, sterile device, the Truject is intended for use in hospital settings, including general medical and vascular care environments. It is regulated under FDA 510(k) clearance (K945284) and is manufactured by Clive Craig Co. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.

Other devices from Clive Craig Co.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of medical procedures is the Truject designed to assist with in vascular care?

    The Truject is specifically designed for precise vascular access in peripheral arteries, making it useful for delivering contrast agents, guidewires, or therapeutic devices during diagnostic and interventional radiology procedures. Its small-diameter catheter minimizes trauma, ensuring safer and more accurate interventions in general medical and vascular care settings.

  • Is the Truject intended for reuse, or is it meant to be used only once?

    The Truject is supplied as a single-use device, meaning it is intended for one-time use only. This design ensures sterility and reduces the risk of contamination or cross-infection, which is critical for maintaining patient safety in sterile medical procedures.

  • How should the Truject be stored to maintain its sterility before use?

    Since the Truject is a sterile device, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging, protecting it from physical damage, and ensuring it remains uncontaminated until immediately before use in a clinical setting.

  • What regulatory pathway was followed for the Truject’s FDA clearance, and what does that mean for its use?

    The Truject received FDA 510(k) clearance (K945284) under a *Traditional* review process, determined to be *Substantially Equivalent* to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as a femoral microcatheter (FMI) and can be legally marketed and used in hospital settings for its intended applications.