Methyl Methacrylate For Aneurysmorrhaphy

Device Code: 3732

Product Code(s): JXH

Device Classification Information

Device Type ID3732
Device NameMethyl Methacrylate For Aneurysmorrhaphy
Regulation DescriptionMethyl Methacrylate For Aneurysmorrhaphy.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurointerventional Devices Branch (NIDB)
Submission Type510(k)
CFR Regulation Number882.5030 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJXH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3732
DeviceMethyl Methacrylate For Aneurysmorrhaphy
Product CodeJXH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethyl Methacrylate For Aneurysmorrhaphy.
CFR Regulation Number882.5030 [🔎]
TPLC Last Update: 2019-04-02 20:35:39

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