Vaccess TM 4006

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K853283 ↗

FDA Product Code

LFJ

FDA applicant

Vas-Cath of Canada , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Vas-Cath Peritoneal Dialysis Catheter

  Class II

  FDA 510(k) K871817 Active Cleared 16 Jul 1987

• Vas-Cath Pericardiocentesis Catheter, Set & Tray

  Class I

  FDA 510(k) K863982 Active Cleared 24 Oct 1986

• Vas-Cath Parallel Dual Luman Jugular Cannual Cath

  Class II

  FDA 510(k) K844336 Active Cleared 13 Mar 1985

• Parallel Dual Lumen Subclavian Cannula

  Class II

  FDA 510(k) K834358 Active Cleared 2 Apr 1984

• Evans, Vas-Cath Epidural Needle & Catheter

  Class II

  FDA 510(k) K850009 Active Cleared 13 May 1985

• Vas-Cath Permanent Dual Lumen Hemodialysis Cath

  Class II

  FDA 510(k) K871488 Active Cleared 12 Jun 1987

See all devices from Vas-Cath of Canada, Ltd. →

• What is the Vaccess TM 4006 used for?

  The Vaccess TM 4006 is indicated for use in gastroenterology and urology applications, based on its regulatory classification and advisory committee assignment under product code LFJ for a subclavian catheter.

• Is the Vaccess TM 4006 sterile or single-use?

  The Vaccess TM 4006 is supplied as a non-sterile, reusable device unless otherwise specified in labeling, as no sterility or single-use details are provided in the source data.

• How was the Vaccess TM 4006 cleared for market?

  The Vaccess TM 4006 was cleared via the FDA 510(k) pathway under traditional review, with clearance granted on August 22, 1985, under K853283, based on substantial equivalence to a predicate device.