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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device controller, temperature, cardiopulmonary bypass
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeDWC
Regulation Number 870.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 CardioQuip, LLC II Dec-15-2023
2 CardioQuip, LLC II Dec-01-2023
3 CardioQuip, LLC II Oct-07-2021
4 CardioQuip, LLC II Oct-06-2021
5 Cincinnati Sub-Zero Products LLC II Feb-13-2018
6 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
7 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Oct-03-2018
8 Gentherm Medical, LLC II Jul-19-2021
9 LivaNova Deutschland GmbH II Oct-06-2023
10 LivaNova USA II May-18-2018
11 LivaNova USA Inc. II Mar-13-2020
12 LivaNova USA Inc. II Oct-25-2019
13 LivaNova USA Inc. II Apr-06-2019
14 Maquet Medical Systems USA II Jul-23-2021
15 Terumo Cardiovascular Systems Corporation II Jun-04-2021
16 Terumo Cardiovascular Systems Corporation II Apr-18-2018
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