Vaccess 2000 Single Lumen Subclavian Cannula

• • Terminated Z-1229-2007 FDA Unclassified (pre-2012) ·initiated 10 Aug 2007 ·on shared 510(k) K844433

  Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K844433 ↗

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

• Vaccess TM 4006

  Class II

  FDA 510(k) K853283 Active Cleared 22 Aug 1985

• 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

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