Stent Delivery System

Device Code: 1082

Product Code(s): PKK

Definition: For Coarctation Of The Aorta

Device Classification Information

Device Type ID1082
Device NameStent Delivery System
Physical StateFor Coarctation Of The Aorta
Technical MethodFor Coarctation Of The Aorta
Target AreaAorta
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodePKK
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1082
DeviceStent Delivery System
Product CodePKK
TPLC Last Update: 2019-04-02 19:48:08

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