Device Type ID | 3732 |
Device Name | Methyl Methacrylate For Aneurysmorrhaphy |
Regulation Description | Methyl Methacrylate For Aneurysmorrhaphy. |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
Submission Type | 510(k) |
CFR Regulation Number | 882.5030 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | JXH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3732 |
Device | Methyl Methacrylate For Aneurysmorrhaphy |
Product Code | JXH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Methyl Methacrylate For Aneurysmorrhaphy. |
CFR Regulation Number | 882.5030 [🔎] |