Agent, Occluding, Vascular, Permanent

Device Code: 1081

Product Code(s): PJQ

Definition: The Device Is A Polymerizing Agent Intended For Permanent Occlusion Of Peripheral Blood Vessels.

Device Classification Information

Device Type ID1081
Device NameAgent, Occluding, Vascular, Permanent
Physical StateThe Device Consists Of A Polymerizing Glue And Delivery System For Injection Into The Vasculature.
Technical MethodThe Material Polymerizes In The Vessel To Permanently Coapt Or Occlude The Vessel.
Target AreaPeripheral Vasculature
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodePJQ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1081
DeviceAgent, Occluding, Vascular, Permanent
Product CodePJQ
FDA Device ClassificationClass 3 Medical Device
Device Problems
Adverse Event Without Identified Device Or Use Problem
193
Migration Or Expulsion Of Device
4
Material Deformation
4
Partial Blockage
2
Defective Device
2
Detachment Of Device Or Device Component
2
Device Operates Differently Than Expected
2
Material Puncture / Hole
2
Obstruction Of Flow
2
Deformation Due To Compressive Stress
2
Use Of Device Problem
1
Failure To Deliver
1
Device Difficult To Setup Or Prepare
1
Occlusion Within Device
1
Misfire
1
Torn Material
1
Break
1
Mechanical Problem
1
Stretched
1
Therapy Delivered To Incorrect Body Area
1
Off-Label Use
1
Total Device Problems 226
Recalls
Manufacturer Recall Class Date Posted
1
Covidien LLC
II May-12-2015
TPLC Last Update: 2019-04-02 19:48:07

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