FDA product code MGZ: Valvulotome
MGZ is the FDA product code for valvulotome. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel. FDA has cleared 27 510(k) submissions under MGZ, 3 in the last five years, from 17 different applicants. The average 510(k) review took 191 days (median 163); 112 days on average over the last three years. FDA has posted 6 recalls for MGZ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Valvulotome |
| Device class | Class II |
| Regulation | 21 CFR 870.4885 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 264 |
| 2022 | 1 | 174 |
| 2025 | 1 | 169 |
| 2026 | 1 | 55 |
Compare with all 510(k) review times · Search every MGZ clearance
Top MGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| LeMaitre Vascular, Inc. | 5 | 2014-10-17 |
| Vascutech, Inc. | 4 | 1999-02-12 |
| LimFlow, Inc. | 2 | 2026-03-18 |
| Intramed Laboratories, Inc. | 2 | 1994-02-10 |
| Cardio Source | 2 | 1991-10-18 |
12 more applicants have MGZ clearances. See the full list in Caduvo.
Most recent MGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260188 | LimFlow, Inc. | LimFlow Vector | 2026-03-18 | 55 |
| K250105 | Aveera Medical, Inc. | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | 2025-07-03 | 169 |
| K221902 | LimFlow, Inc. | LimFlow Vector | 2022-12-21 | 174 |
| K190267 | Lemaitre Vascular | EZE SIT Valvulotome | 2019-10-30 | 264 |
| K142660 | LeMaitre Vascular, Inc. | Antegrade LeMills Valvulotome | 2014-10-17 | 29 |
Recalls for MGZ devices
6 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-12-05.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MGZ?
MGZ is the FDA product code for valvulotome. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel.
What device class is MGZ?
Class II, regulation 21 CFR 870.4885. Typical premarket route: 510(k).
How long does a 510(k) take for product code MGZ?
Across 27 cleared submissions the average was 191 days from receipt to decision (median 163).
Which companies have the most MGZ clearances?
LeMaitre Vascular, Inc. (5); Vascutech, Inc. (4); LimFlow, Inc. (2); Intramed Laboratories, Inc. (2); Cardio Source (2).
Have MGZ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2025-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MGZ
- Run a recall and safety report across every MGZ manufacturer
- Watch product code MGZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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