Trillium Affinity Nt Cardiotomy Venous Reservoir, Models 540T, 541TT

• • Terminated Z-0646-2018 FDA Class II ·initiated 16 Jan 2018

  Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.

510(k) Number

K021287 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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