MGZ
- Product code
- MGZ
- Device name
- Valvulotome
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4885
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 27 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260188 | 2026-03-18 | LimFlow, Inc. | LimFlow Vector | |
| K250105 | 2025-07-03 | Aveera Medical, Inc. | Boomerang Valvulotome (BMGVT080); Boomerang Push Val… |
Official FDA classification page: MGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).