Catheter, Percutaneous, Long Term, Intraspinal

Device Code: 2857

Product Code(s): LNY

Device Classification Information

Device Type ID2857
Device NameCatheter, Percutaneous, Long Term, Intraspinal
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLNY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2857
DeviceCatheter, Percutaneous, Long Term, Intraspinal
Product CodeLNY
FDA Device ClassificationClass 3 Medical Device
Device Problems
Catheter
2
Unknown (for Use When The Device Problem Is Not Known)
1
Occlusion Within Device
1
Fracture
1
Migration Or Expulsion Of Device
1
Device Operates Differently Than Expected
1
Leak / Splash
1
Fluid Leak
1
Split
1
Total Device Problems 10
TPLC Last Update: 2019-04-02 20:20:07

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