MGZ

Valvulotome

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)

Last three years. Most recent: 2026-03-18.

NumberDecision dateApplicantDevice nameSummary
K2601882026-03-18LimFlow, Inc.LimFlow VectorPDF
K2501052025-07-03Aveera Medical, Inc.Boomerang Valvulotome (BMGVT080); Boomerang Push Val…PDF

2 summaries are archived here for direct download.

Official FDA classification page: MGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).