Clamp, Carotid Artery

Device Code: 3723

Product Code(s): HCE

Device Classification Information

Device Type ID3723
Device NameClamp, Carotid Artery
Regulation DescriptionCarotid Artery Clamp.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.5175 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHCE
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3723
DeviceClamp, Carotid Artery
Product CodeHCE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCarotid Artery Clamp.
CFR Regulation Number882.5175 [🔎]
TPLC Last Update: 2019-04-02 20:35:20

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