Ibc Cardiac Suction Ward

• • Terminated Z-2422-2015 FDA Class II ·initiated 7 Aug 2015

  It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

• • Terminated Z-0273-2012 FDA Unclassified (pre-2012) ·initiated 5 Oct 2011

  Potential for the sterility to be compromised.

510(k) Number

K963756 ↗

FDA Product Code

DTS

Device Class

Class II

Regulation

21 CFR Part 870.4420

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• IBC Vent Valve, Model 1400

  Class II

  FDA 510(k) K992964 Active Cleared 19 Nov 1999

• Ibc Vrv, Model 1350

  Class II

  FDA 510(k) K992657 Active Cleared 18 Feb 2000

• CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4

  Class II

  FDA 510(k) K963698 Active Cleared 20 Mar 1997

• Ibc Floguard, Model 6050

  Class II

  FDA 510(k) K992785 Active Cleared 14 Jan 2000

• Accuflo Monitoring System (1800)/ Accuflo Probe (8000)

  Class II

  FDA 510(k) K963703 Active Cleared 8 Apr 1998

• Lifechoice Oxygen Concentrator, Model OXY1000

  Class II

  FDA 510(k) K072688 Active Cleared 11 Jan 2008

See all devices from International Biophysics Corp. →