Defoamer, Cardiopulmonary Bypass

Device Code: 792

Product Code(s): DTP

Device Classification Information

• Device Type ID: 792
• Device Name: Defoamer, Cardiopulmonary Bypass
• Regulation Description: Cardiopulmonary Bypass Defoamer.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Circulatory Support Devices Branch (CSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.4230 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DTP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 792
• Device: Defoamer, Cardiopulmonary Bypass
• Product Code: DTP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cardiopulmonary Bypass Defoamer.
• CFR Regulation Number: 870.4230 [🔎]

Device Problems
Suction Problem	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:41:37