| Device Type ID | 3725 |
| Device Name | Clip, Aneurysm |
| Regulation Description | Aneurysm Clip. |
| 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 | 882.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3725 |
| Device | Clip, Aneurysm |
| Product Code | HCH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aneurysm Clip. |
| CFR Regulation Number | 882.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 9 |
Difficult To Open Or Close | 7 |
Mechanical Problem | 7 |
Insufficient Information | 3 |
Defective Device | 2 |
Loose Or Intermittent Connection | 2 |
Material Deformation | 2 |
Clip | 2 |
Device Handling Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Material Twisted / Bent | 2 |
Device Component Or Accessory | 1 |
Fracture | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Integrity Problem | 1 |
Migration | 1 |
Seal | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Clamp | 1 |
Normal | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Firing Problem | 1 |
Failure To Align | 1 |
| Total Device Problems | 54 |