Bivona Fome-Cuf(R) & Air Cuf(R), Modification

• • Terminated Z-0339-2007 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006

  Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

• • Terminated Z-0046-2007 FDA Unclassified (pre-2012) ·initiated 11 Aug 2006

  The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

510(k) Number

K913859 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

  Class II

  FDA 510(k) K792035 Active Cleared 26 Oct 1979

• Aire-Cuf Polyester Re-Enforced Endotracheal Tube

  Class II

  FDA 510(k) K872366 Active Cleared 17 Aug 1987

• Fome-Cuf Pvc

  Class II

  FDA 510(k) K780583 Active Cleared 12 May 1978

• Fome-Cuf and Aire Cuf Tracheostomy Tubes

  Class II

  FDA 510(k) K862267 Active Cleared 18 Jun 1986

• Bivona Nasal Turbinate Stent

  Class I

  FDA 510(k) K935053 Active Cleared 1 Jul 1994

• Bivona Carden Intermittent Jetting Device

  Class II

  FDA 510(k) K895946 Active Cleared 9 Jan 1990

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