Levitronix Pedimag Blood Pump, Model 201-90052

• • Terminated Z-0103-2019 FDA Class II ·initiated 5 Sep 2018

  Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

510(k) Number

K090051 ↗

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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