Cycler Sets Mod. #5C4143, 5C4144, 5C4145

• • Terminated Z-0194-2016 FDA Class II ·initiated 6 Oct 2015

  Leakage from the inlet port of the 15L Cycler Drainage Bags.

• • Terminated Z-0080-2015 FDA Class II ·initiated 17 Oct 2013

  The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

510(k) Number

K791899 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

• Arteoial Blood Sampling Kit 2D9014

  Class II

  FDA 510(k) K771584 Active Cleared 13 Sep 1977

• Blood-Solution Administration Set, Surg.

  Class I

  FDA 510(k) K760483 Active Cleared 3 Sep 1976

• Flo-Gard 8000 Computer Control Infusi

  Class II

  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →