Hemocor Hph 700 Hemoconcentrator

• • Terminated Z-2735-2015 FDA Class II ·initiated 18 Aug 2015

  Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

• • Terminated Z-2761-2015 FDA Class II ·initiated 3 Aug 2015

  Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.

510(k) Number

K983085 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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