| Device Type ID | 808 |
| Device Name | Stripper, Vein, External |
| Regulation Description | External Vein Stripper. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4885 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWQ |
| 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 | 808 |
| Device | Stripper, Vein, External |
| Product Code | DWQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Vein Stripper. |
| CFR Regulation Number | 870.4885 [🔎] |
| Device Problems | |
|---|---|
Failure To Conduct | 24 |
Device Inoperable | 10 |
Electrical /Electronic Property Problem | 6 |
Device Stops Intermittently | 5 |
Device Operational Issue | 4 |
Failure To Auto Stop | 2 |
Difficult To Remove | 1 |
Disconnection | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | LeMaitre Vascular, Inc. | III | Mar-18-2015 |