Central Catheter Tray

• 2 recalls, same reason

  • Terminated Z-1738-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010 ·on shared 510(k) K781333
  • Terminated Z-1739-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010

  There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

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

510(k) Number

K781333 ↗

FDA Product Code

KGC

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• V-Stick Vascular Access Set

  Class II

  FDA 510(k) K130730 Active Cleared 22 Nov 2013

• Digicath

  Class II

  FDA 510(k) K831171 Active Cleared 25 May 1983

• Central Catheter Kit

  Class II

  FDA 510(k) K780673 Active Cleared 16 May 1978

• Argon Dual Lumen Hemodialysis, Catheter

  Class II

  FDA 510(k) K842039 Active Cleared 29 Jan 1985

• Translumbar Aortography Needle Catheter

  Class II

  FDA 510(k) K884375 Active Cleared 11 Jan 1989

• Introducer for Ptca Guiding Catheters

  Class II

  FDA 510(k) K891022 Active Cleared 19 May 1989

See all devices from Argon Medical Corp. →