Mikro-Tip Angiographic Catheter

• • Terminated Z-1725-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011

  Possibility of epoxy debris particles inside the catheter lumen.

• • Terminated Z-0401-2011 FDA Unclassified (pre-2012) ·initiated 14 Oct 2010

  The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.

510(k) Number

K952773 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Transducer-Monitor Interfacing

  Class II

  FDA 510(k) K842150 Active Cleared 26 Oct 1984

• Cardia-Cath

  Class II

  FDA 510(k) K112323 Active Cleared 18 Oct 2011

• Millar Pressure Control Unit Model Pcu-2000

  Class II

  FDA 510(k) K013205 Active Cleared 2 Jul 2002

• Mikro-Tip Cath. Pressure Transducer

  Class II

  FDA 510(k) K830909 Active Cleared 18 Apr 1983

• Millar Mikro-Tip Pulse Transducer

  Class II

  FDA 510(k) K895721 Active Cleared 7 Dec 1989

• Mikro-Tip Angiographic Catheter

  Class II

  FDA 510(k) K993694 Active Cleared 1 Mar 2000

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