Carbomedics Valve Tester

• • Terminated Z-0738-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2002

  Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.

510(k) Number

K960169 ↗

FDA Product Code

DTJ

Device Class

Class I

Regulation

21 CFR Part 870.3935

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Minature Pressure Transducer

  Class II

  FDA 510(k) K834040 Active Cleared 10 Feb 1984

• Hydroxylapatite Alveolar Ridge Main

  Class II

  FDA 510(k) K810382 Active Cleared 20 Mar 1981

• Valve Sizer

  Class I

  FDA 510(k) K934951 Active Cleared 10 Dec 1993

• Pyrolite Carbon Alveolar Mainten Implant

  Class II

  FDA 510(k) K791416 Active Cleared 9 Oct 1979

• Carbomedics Supra-Annular Valve Sizer

  Class I

  FDA 510(k) K952184 Active Cleared 29 Nov 1995

• Carbomedics Mitral Rotator

  Class I

  FDA 510(k) K960923 Active Cleared 29 Apr 1996

See all devices from Carbomedics, Inc. →