Transducer, Vessel Occlusion

Device Code: 823

Product Code(s): DXP

Device Classification Information

Device Type ID823
Device NameTransducer, Vessel Occlusion
Regulation DescriptionVessel Occlusion Transducer.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.2890 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDXP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID823
DeviceTransducer, Vessel Occlusion
Product CodeDXP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVessel Occlusion Transducer.
CFR Regulation Number870.2890 [🔎]
TPLC Last Update: 2019-04-02 19:42:26

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