| Device Type ID | 3628 |
| Device Name | Guide, Wire, Catheter, Neurovasculature |
| Regulation Description | Catheter Guide Wire. |
| Regulation Medical Specialty | Cardiovascular |
| 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 | 870.1330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MOF |
| 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 | 3628 |
| Device | Guide, Wire, Catheter, Neurovasculature |
| Product Code | MOF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Guide Wire. |
| CFR Regulation Number | 870.1330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASAHI | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ASAHI INTECC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BALT USA, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CODMAN & SHURTLEFF, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON & JOHNSON PROFESSIONALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICROVENTION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Peeled / Delaminated | 6 |
Insufficient Information | 5 |
Break | 4 |
Detachment Of Device Component | 3 |
Delamination | 3 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 33 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Microvention, Inc. | II | Sep-01-2017 |