Clean-Cuff

• • Terminated Z-3274-2011 FDA Unclassified (pre-2012) ·initiated 25 Aug 2011

  Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description.

510(k) Number

K952038 ↗

FDA Product Code

KCY

Device Class

Class I

Regulation

21 CFR Part 878.5910

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Accuflate Accessorie Cart W/IV Pole and Clamp

  Class I

  FDA 510(k) K924373 Active Cleared 25 Nov 1992

• Accuflate

  Class I

  FDA 510(k) K924273 Active Cleared 12 Jan 1993

• Light Reflection Rheography

  Class II

  FDA 510(k) K833561 Active Cleared 8 Jan 1985

• Accutest

  Class I

  FDA 510(k) K940615 Active Cleared 19 May 1995

• Disposable Color-Cuffs

  Class I

  FDA 510(k) K890014 Active Cleared 24 Jan 1989

• Polypet

  Class I

  FDA 510(k) K860617 Active Cleared 3 Mar 1986

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