Deseret Subclavian Jugular Cath. Set

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

510(k) Number

K834227 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

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

See all devices from Parke-Davis Co. →

• What is the primary purpose of the Deseret Subclavian Jugular Cath. Set, and how long is it intended for use?

  The Deseret Subclavian Jugular Cath. Set is designed for temporary vascular access, specifically for insertion into the subclavian or jugular vein. It is classified as a short-term device, intended for use for less than 30 days in general hospital settings.

• Is this catheter set single-use or reusable, and how is it supplied?

  The Deseret Subclavian Jugular Cath. Set is supplied as a complete catheter set, but the data does not specify whether it is single-use or reusable. Typically, short-term catheters like this are single-use due to infection control and sterility concerns, though this should be confirmed with the manufacturer.

• What regulatory pathway was followed for FDA clearance of this device, and when was it cleared?

  The Deseret Subclavian Jugular Cath. Set was cleared through the FDA’s 510(k) pathway under traditional review, with a clearance decision dated March 19, 1984. The device was determined to be substantially equivalent to a legally marketed predicate, as indicated by the clearance type and decision code.

• Where is this device manufactured, and what type of facility is it intended for?

  The device is manufactured by Parke-Davis Co., and it is specifically intended for use in general hospital settings, as noted in the advisory committee description during its regulatory review.