Antegrade LeMills Valvulotome
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142660 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)
Antegrade LeMills Valvulotome is a valvulotome device used in cardiovascular procedures. It is designed for the incision of venous valves during vascular surgery.
The device is supplied non-sterile and is intended for single use. It is regulated as a Class II medical device under FDA 510(k) clearance K142660, with product code MGZ and regulation number 870.4885.
Frequently asked questions
What is the Antegrade LeMills Valvulotome used for?
The Antegrade LeMills Valvulotome is used to incise venous valves during cardiovascular procedures, enabling improved blood flow in vascular surgery by cutting obstructive valves in veins.
Is the Antegrade LeMills Valvulotome sterile when supplied?
The device is supplied non-sterile, meaning it must be sterilized by the user prior to use; this is specified in the device data and affects how it should be handled in clinical settings.
Can the Antegrade LeMills Valvulotome be reused after a procedure?
The device is intended for single use only, as stated in the description, and should not be reprocessed or reused due to risks of material degradation, contamination, or loss of function.
What regulatory pathway was used for the Antegrade LeMills Valvulotome?
The device received FDA 510(k) clearance under submission K142660, classified as a Class II medical device with product code MGZ and regulation number 870.4885, indicating it was found substantially equivalent to a predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142660 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA 510(k) K142660 24 fields · synced Sep 21, 2026