Accessory Equipment, Cardiopulmonary Bypass

Device Code: 856

Product Code(s): KRI

Device Classification Information

• Device Type ID: 856
• Device Name: Accessory Equipment, Cardiopulmonary Bypass
• Regulation Description: Cardiopulmonary Bypass Accessory Equipment.
• 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: 870.4200 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KRI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 856
• Device: Accessory Equipment, Cardiopulmonary Bypass
• Product Code: KRI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Cardiopulmonary Bypass Accessory Equipment.
• CFR Regulation Number: 870.4200 [🔎]

Device Problems
Other (for Use When An Appropriate Device Code Cannot Be Identified)	2
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Maquet Cardiopulmonary Ag	II	May-04-2018
2	Terumo Cardiovascular Systems Corp	II	Oct-31-2014

TPLC Last Update: 2019-04-02 19:43:32