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TPLC
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show TPLC since
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Device
system, catheter control, steerable
Product Code
DXX
Regulation Number
870.1290
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORINDUS, INC.
SUBSTANTIALLY EQUIVALENT
5
MDR Year
MDR Reports
MDR Events
2017
3
3
2018
9
9
2019
9
9
2020
4
4
2021
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
3
3
Component or Accessory Incompatibility
3
3
Fail-Safe Problem
3
3
Electrical /Electronic Property Problem
2
2
Break
2
2
Display or Visual Feedback Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Electrical Shorting
2
2
Material Deformation
1
1
Power Problem
1
1
Product Quality Problem
1
1
Device-Device Incompatibility
1
1
Fail-Safe Did Not Operate
1
1
Device Operational Issue
1
1
Patient Device Interaction Problem
1
1
Device Issue
1
1
Mechanical Problem
1
1
Insufficient Information
1
1
Activation Problem
1
1
Device Displays Incorrect Message
1
1
Thermal Decomposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
12
12
No Consequences Or Impact To Patient
10
10
No Clinical Signs, Symptoms or Conditions
2
2
Vascular Dissection
1
1
Paresthesia
1
1
Insufficient Information
1
1
Chest Pain
1
1
No Patient Involvement
1
1
Vertigo
1
1
Speech Disorder
1
1
Electric Shock
1
1
Movement Disorder
1
1
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