Sensor, Pressure, Aneurysm, Implantable

Device Code: 919

Product Code(s): NQH

Definition: This Device Is Intended To Measure The Pressure In The Aneurysm Sac During And After An Endovascular Procedure.

Device Classification Information

Device Type ID919
Device NameSensor, Pressure, Aneurysm, Implantable
Regulation DescriptionImplantable Intra-aneurysm Pressure Measurement System.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type510(k)
CFR Regulation Number870.2855 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNQH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID919
DeviceSensor, Pressure, Aneurysm, Implantable
Product CodeNQH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplantable Intra-aneurysm Pressure Measurement System.
CFR Regulation Number870.2855 [🔎]
TPLC Last Update: 2019-04-02 19:44:52

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