Data / Medical devices / Valvulotome
Valvulotome (MGZ): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Valvulotome (product code MGZ, Class 2, 21 CFR 870.4885). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on March 18, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MGZ
- Device class
- 2
- Regulation
- 870.4885
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 2 |
| Costa Rica | 1 |
Makers of Valvulotome
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 4 | October 30, 2019 | 0 | 2 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 4 | October 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| LimFlow Inc. | Irvine, CA, United States | Specification developer | 2 | March 18, 2026 | 0 | 1 | 0 | api.fda.gov |
| Aveera Medical | San Clemente, CA, United States | Complaint file establishment, Manufacturer | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Geister Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 1 | July 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | June 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | June 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Contract Medical International GmbH | DRESDEN Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.