Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132190 FDA 510(k)
- FDA Product Code
- MGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4885 FDA 510(k)
- Regulation Number
- 870.4885 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome is a vascular cutting device designed for valvulotomy procedures. It is classified as a valvulotome, intended for use in the cardiovascular system to incise or resect venous valves, particularly in the treatment of venous insufficiency or other valvular disorders.
This device is supplied as a reusable, over-the-wire instrument and is intended for use in controlled clinical settings such as operating rooms or catheterization labs. It is regulated under FDA 510(k) clearance (K132190) and EU MDR compliance, with a product code of MGZ. The device is not indicated for MRI use and must be handled according to sterile reprocessing protocols. Sizes and configurations are specified in the manufacturer’s technical documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Over-the-Wire LeMaitre® Valvulotome, LeMaitre® Valvulotome, PDF Expandable LeMaitre Valvulotome - ANGIO MEDICAL, Expandable Lemaitre Valvulotome, Over-the-wire Lemaitre Valvulotome ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K132190 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (2)
- FDA 510(k) K132190 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026