Product Classification

• Device: controller, temperature, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass temperature controller.
• 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).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DWC
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: 510(k)
• Regulation Number: 870.4250
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standard

• 19-42 IEC 61326-1 Edition 3.0 2020-10
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

Third Party Review

Not Third Party Eligible