Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack

• • Terminated Z-0968-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.

• • Terminated Z-0359-2009 FDA Unclassified (pre-2012) ·initiated 14 Feb 2008

  The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.

510(k) Number

K935391 ↗

FDA Product Code

GFA

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Monitor Kits, Blood Level

  Class II

  FDA 510(k) K781145 Active Cleared 27 Jul 1978

• 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System

  Class II

  FDA 510(k) K950739 Active Cleared 17 Nov 1995

• Flexible Arterial Cannulae

  Class II

  FDA 510(k) K771499 Active Cleared 16 Aug 1977

• Battery Operated Flow Rate Computer

  Class II

  FDA 510(k) K760756 Active Cleared 15 Oct 1976

• Centrifugal Pump System Lx/Dx Version

  Class II

  FDA 510(k) K882758 Active Cleared 13 Oct 1988

• Clear Cardioplejia Delivery System

  Class II

  FDA 510(k) K823451 Active Cleared 14 Jan 1983

See all devices from 3M Health Care, Sarns →