Cardio Metric Custom Perfusion Tubing

• • Terminated Z-1222-06 FDA Unclassified (pre-2012) ·initiated 16 Aug 2005

  Tyvek pouches containing device labeled as sterile have defective seals.

510(k) Number

K841959 ↗

FDA Product Code

DWE

Device Class

Class II

Regulation

21 CFR Part 870.4390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Custom Sterile Procedure Kits

  Not classified

  FDA 510(k) K842356 Active Cleared 21 Mar 1985

• Sterile Design-Custom Sterile IV Kit

  Class II

  FDA 510(k) K842351 Active Cleared 15 Oct 1984

• Pan Set

  Class II

  FDA 510(k) K813437 Active Cleared 31 Dec 1981

• Custom Dressing Change Trays

  Class I

  FDA 510(k) K791738 Active Cleared 2 Oct 1979

• Cardio Metrics Cardiotomy Reservoir

  Class II

  FDA 510(k) K841958 Active Cleared 15 Oct 1984

• Graduated Guide Wire Bowl 8

  Class II

  FDA 510(k) K834237 Active Cleared 4 Feb 1984

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