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TPLC
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Device
system, catheter control, steerable
Regulation Description
Steerable catheter control system.
Product Code
DXX
Regulation Number
870.1290
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORINDUS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
4
4
2021
5
5
2022
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2
2
Component or Accessory Incompatibility
2
2
Electrical /Electronic Property Problem
2
2
Electrical Shorting
2
2
Labelling, Instructions for Use or Training Problem
2
2
Device Handling Problem
1
1
Thermal Decomposition of Device
1
1
Fail-Safe Did Not Operate
1
1
Inadequate User Interface
1
1
Human-Device Interface Problem
1
1
Mechanical Problem
1
1
Power Problem
1
1
Insufficient Information
1
1
Material Deformation
1
1
Activation Problem
1
1
Unintended Movement
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
9
9
No Clinical Signs, Symptoms or Conditions
4
4
No Consequences Or Impact To Patient
2
2
No Patient Involvement
1
1
Chest Pain
1
1
Vascular Dissection
1
1
Speech Disorder
1
1
Vertigo
1
1
Paresthesia
1
1
Insufficient Information
1
1
Movement Disorder
1
1
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