Solution Admin. Set 2C9096 W/10 Pvc

• • Terminated Z-0193-05 FDA Unclassified (pre-2012) ·initiated 28 Apr 2004

  Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.

• • Terminated Z-1157-03 FDA Unclassified (pre-2012) ·initiated 16 Jul 2003

  There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

510(k) Number

K832284 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

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. →