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Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000, VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251238

by Maquet Cardiovascular LLC

Identifiers

510(k) Number
K251238 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) FDA 510(k)EUDAMED
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001) FDA 510(k)EUDAMED
Vasoview Hemopro 3 Power Supply (VH-6010) FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is a minimally invasive device designed for endoscopic harvesting of blood vessels, such as the saphenous vein. It combines endoscopic visualization with specialized instruments to facilitate precise vessel extraction, reducing trauma and improving surgical outcomes. The system includes components for both standard vessel harvesting and an optional protective coating (Vasoshield) to enhance vessel integrity during the procedure.

The system is supplied as a reusable endoscopic unit paired with single-use disposable components, including the harvesting instruments and power supply (VH-6010). It is intended for use in surgical settings, with sterility maintained through standard medical device processing protocols. The device complies with FDA 510(k) clearance under the General, Plastic Surgery advisory committee and adheres to MDD regulatory standards. Sizes and configurations are standardized for compatibility with endoscopic surgical techniques.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maquet Cardiovascular LLC
FDA Applicant
Maquet Cardiovascular, LLC

Sources (2)

  • FDA 510(k) K251238 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026