Sarns 7850 Centrifugal Pump (Modified)

• • Terminated Z-0545-2010 FDA Unclassified (pre-2012) ·initiated 6 Jul 2009

  The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

510(k) Number

K915363 ↗

FDA Product Code

KFM

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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