Product Classification

• Device: system, thermal regulating
• Regulation Description: Thermal regulating system.
• 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: DWJ
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: 510(k)
• Regulation Number: 870.5900
• 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?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc