• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, catheter control, steerable
Product CodeDXX
Regulation Number 870.1290
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component or Accessory Incompatibility 3 3
Fail-Safe Problem 3 3
Unintended Movement 3 3
Break 2 2
Display or Visual Feedback Problem 2 2
Electrical /Electronic Property Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Electrical Shorting 2 2
Mechanical Problem 1 1
Product Quality Problem 1 1
Device Issue 1 1
Device Displays Incorrect Message 1 1
Thermal Decomposition of Device 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Activation Problem 1 1
Fail-Safe Did Not Operate 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Material Deformation 1 1
Power Problem 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 3 3
Electric Shock 1 1
No Patient Involvement 1 1
Chest Pain 1 1
Vertigo 1 1
Vascular Dissection 1 1
Movement Disorder 1 1
Speech Disorder 1 1
Paresthesia 1 1
Insufficient Information 1 1

-
-