Filter, Prebypass, Cardiopulmonary Bypass

Device Code: 857

Product Code(s): KRJ

Device Classification Information

• Device Type ID: 857
• Device Name: Filter, Prebypass, Cardiopulmonary Bypass
• Regulation Description: Cardiopulmonary Prebypass Filter.
• 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) Exempt
• CFR Regulation Number: 870.4280 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KRJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 857
• Device: Filter, Prebypass, Cardiopulmonary Bypass
• Product Code: KRJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cardiopulmonary Prebypass Filter.
• CFR Regulation Number: 870.4280 [🔎]

Device Problems
Failure To Prime	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:43:33