Life-Line Vascular Access System

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

Full name

Life-Line(Tm) Vascular Access System

510(k) Number

K895030 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Locking Wire Guide Stylet

  Class I

  FDA 510(k) K890820 Active Cleared 22 Mar 1989

• Byrd Dilator Sheath Set - Teflon

  Class II

  FDA 510(k) K902469 Active Cleared 23 Aug 1990

• Byrd Extractor Set

  Class I

  FDA 510(k) K893480 Active Cleared 23 Jun 1989

• Workstation Femoral Intravascular Retrieval Set

  Class II

  FDA 510(k) K902477 Active Cleared 24 Aug 1990

• Byrd Stainless Steel Dilator

  Class I

  FDA 510(k) K902502 Active Cleared 7 Aug 1990

• What is the Life-Line Vascular Access System used for?

  The Life-Line Vascular Access System is a port and catheter device designed for vascular access procedures in a general hospital setting. It is implanted subcutaneously and intravascularly to provide access to the vascular system.

• How is the Life-Line Vascular Access System supplied?

  The device is supplied as part of a kit. It is intended for single use and requires appropriate storage conditions to maintain its integrity until use.

• What is the regulatory classification of the Life-Line Vascular Access System?

  The device is regulated under FDA 510(k) clearance K895030 with product code LJT. It is classified as a Class II device and is regulated under number 880.5965.

• Is the Life-Line Vascular Access System reusable?

  No, the Life-Line Vascular Access System is intended for single use only. It should not be reused on multiple patients or for multiple procedures.