| Device Type ID | 807 |
| Device Name | Dilator, Vessel, Surgical |
| Regulation Description | Surgical Vessel Dilator. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4475 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWP |
| 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 | 807 |
| Device | Dilator, Vessel, Surgical |
| Product Code | DWP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Vessel Dilator. |
| CFR Regulation Number | 870.4475 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 93 |
Unsealed Device Packaging | 2 |
Packaging Problem | 2 |
Break | 1 |
Sticking | 1 |
| Total Device Problems | 99 |