Cpb Check Valve, Retrograde Flow, In-line

Device Code: 875

Product Code(s): MJJ

Device Classification Information

• Device Type ID: 875
• Device Name: Cpb Check Valve, Retrograde Flow, In-line
• Regulation Description: Cardiopulmonary Bypass Blood Reservoir.
• 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: 870.4400 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MJJ
• 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: 875
• Device: Cpb Check Valve, Retrograde Flow, In-line
• Product Code: MJJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cardiopulmonary Bypass Blood Reservoir.
• CFR Regulation Number: 870.4400 [🔎]

Premarket Reviews
Manufacturer	Decision
ATRION CORP.
	SUBSTANTIALLY EQUIVALENT	1
QUEST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Crack	2
Particulates	2
Fluid Leak	1
Missing Value Reason	1
Total Device Problems	6

TPLC Last Update: 2019-04-02 19:44:04