Product Classification

• Device: gauge, pressure, coronary, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass coronary pressure gauge.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DXS
• Premarket Review: Circulatory Support, Structural and Vascular Devices (DHT2B); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: 510(k)
• Regulation Number: 870.4310
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• 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