Controller, Temperature, Cardiopulmonary Bypass
- US Product Code (FDA)
- DWCView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 870.4250View CFR Regulation →
- Medical specialty
- Cardiovascular
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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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Controller, Temperature, Cardiopulmonary Bypass is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.