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Controller, Temperature, Cardiopulmonary Bypass

FDA product code DWC · 29 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4250
Review panel
CV
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
1981-04-03 – 2022-11-16

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).

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