| Device Type ID | 873 |
| Device Name | Valvulotome |
| 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 | MGZ |
| 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 | 873 |
| Device | Valvulotome |
| Product Code | MGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Vein Stripper. |
| CFR Regulation Number | 870.4885 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LEMAITRE VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Difficult To Open Or Close | 19 |
Failure To Align | 9 |
Sticking | 4 |
Material Deformation | 2 |
Material Separation | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Insufficient Information | 1 |
Bent | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 40 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumed International, Inc. | II | Dec-16-2014 |
| 2 | LeMaitre Vascular, Inc. | II | Aug-16-2016 |