Clip, Implanted Malleable

Device Code: 3712

Product Code(s): HBP

Device Classification Information

Device Type ID3712
Device NameClip, Implanted Malleable
Regulation DescriptionImplanted Malleable Clip.
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 Number882.5225 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHBP
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3712
DeviceClip, Implanted Malleable
Product CodeHBP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplanted Malleable Clip.
CFR Regulation Number882.5225 [🔎]
TPLC Last Update: 2019-04-02 20:35:11

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