Detector, Bubble, Cardiopulmonary Bypass

Device Code: 859

Product Code(s): KRL

Device Classification Information

Device Type ID859
Device NameDetector, Bubble, Cardiopulmonary Bypass
Regulation DescriptionCardiopulmonary Bypass Bubble Detector.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type510(k)
CFR Regulation Number870.4205 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKRL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID859
DeviceDetector, Bubble, Cardiopulmonary Bypass
Product CodeKRL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCardiopulmonary Bypass Bubble Detector.
CFR Regulation Number870.4205 [🔎]
Device Problems
False Alarm
7
Device Operational Issue
5
Pumping Stopped
3
Device Alarm System
2
Material Integrity Problem
2
Device Displays Incorrect Message
2
Physical Property Issue
1
Appropriate Term/Code Not Available
1
Bubble Detector
1
Failure To Sense
1
Communication Or Transmission Problem
1
Alarm
1
Incorrect, Inadequate Or Imprecise Result Or Readings
1
Other (for Use When An Appropriate Device Code Cannot Be Identified)
1
Sensing Intermittently
1
Device Issue
1
Total Device Problems 31
TPLC Last Update: 2019-04-02 19:43:35

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