Product Classification

• Device: pump, blood, cardiopulmonary bypass, non-roller type
• Regulation Description: Nonroller-type cardiopulmonary bypass blood pump.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: KFM
• Submission Type: 510(k)
• Regulation Number: 870.4360
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F1830-97 (2005) Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
• ASTM F1841-97 (2005) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

Third Party Review

Not Third Party Eligible