Deseret Long Term Indwelling Catheter

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

510(k) Number

K840958 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Deseret Intravascular Catheter

  Class II

  FDA 510(k) K843033 Active Cleared 3 Dec 1984

• Deseret Neonatal Catheter Set

  Class II

  FDA 510(k) K834393 Active Cleared 13 Feb 1984

• Deseret Heparin Coated Flow Directed

  Class II

  FDA 510(k) K841317 Active Cleared 11 Jun 1984

• Orthopedic Tubular Stockinette

  Class I

  FDA 510(k) K760817 Active Cleared 20 Oct 1976

• Razor, Schick Disposable

  Not classified

  FDA 510(k) K760342 Active Cleared 11 Aug 1976

• Underpad, Disposable Polypropy. (Unilux)

  Class I

  FDA 510(k) K760164 Active Cleared 20 Jul 1976

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• What is the Deseret Long Term Indwelling Catheter used for?

  This device is an intravascular therapeutic catheter designed for long-term use greater than 30 days, allowing repeated access to the vascular system through percutaneous implantation with necessary fittings like luer hubs for therapeutic interventions.

• How is the Deseret Long Term Indwelling Catheter supplied and intended for use?

  It is supplied as a percutaneous, implanted device intended for long-term use, consisting of a slender tube with connecting fittings and accessories that facilitate placement and enable repeated access to the vascular system.

• What regulatory pathway was used for the Deseret Long Term Indwelling Catheter?

  The device received FDA 510(k) clearance (K840958) on April 17, 1984, under regulation number 880.5970, with product code LJS, and is classified as a Class II device for general hospital use based on substantial equivalence to a predicate device.