Device Type ID | 3726 |
Device Name | Applier, Aneurysm Clip |
Regulation Description | Aneurysm Clip Applier. |
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 | 882.4175 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HCI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3726 |
Device | Applier, Aneurysm Clip |
Product Code | HCI |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Aneurysm Clip Applier. |
CFR Regulation Number | 882.4175 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
---|---|
Device Operates Differently Than Expected | 3 |
Difficult To Open Or Close | 1 |
Total Device Problems | 4 |