Stent, Iliac Vein

Device Code: 1087

Product Code(s): QAN

Definition: A Metal Scaffold Placed Via A Delivery Catheter In The Iliac Vein To Maintain The Lumen

Device Classification Information

Device Type ID1087
Device NameStent, Iliac Vein
Physical StateA Metal Scaffold Placed Via A Delivery Catheter
Technical MethodA Metal Scaffold Placed Via A Delivery Catheter In The Iliac Vein To Maintain The Lumen
Target AreaIliac Vein
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeQAN
GMP ExemptNo
Summary MRIneligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1087
DeviceStent, Iliac Vein
Product CodeQAN
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 19:48:12

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