Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000, VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233879 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
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 surgical device designed for endoscopic vessel harvesting. It facilitates the dissection, cutting, and coagulation of tissue, including saphenous veins and radial arteries, during arterial bypass procedures. The system includes endoscopic tools for blunt dissection and precise vessel access, enabling controlled harvesting with reduced trauma. The Vasoshield variant (VH-6001) incorporates additional protective measures during vessel manipulation.
This system is supplied as a reusable surgical instrument set, requiring compatibility with standard endoscopic equipment and power sources. The Power Adapter (VH-6020) ensures proper energy delivery for coagulation and cutting functions. The devices are intended for use in sterile surgical environments and are regulated under FDA 510(k) clearance (K233879) as substantially equivalent to prior-generation endoscopic harvesting tools. No specific MRI safety or single-use designation is stated in the regulatory submission.
Frequently asked questions
What is the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System used for?
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for endoscopic vessel harvesting during arterial bypass procedures. It enables controlled dissection, cutting, and coagulation of tissues such as saphenous veins and radial arteries with reduced trauma compared to traditional methods. The system’s endoscopic tools provide precise access, improving surgical outcomes while minimizing tissue damage.
How is the Vasoview Hemopro 3 system supplied, and what does it require for use?
The system is supplied as a reusable surgical instrument set, meaning it is intended for repeated use in sterile surgical environments. It requires compatibility with standard endoscopic equipment and a power source for coagulation and cutting functions. The included Power Adapter (VH-6020) ensures proper energy delivery, while the Vasoshield variant (VH-6001) adds protective measures during vessel manipulation.
Is the Vasoview Hemopro 3 system single-use or reusable, and what does that mean for sterility?
The Vasoview Hemopro 3 system is designed for reuse, which means it must be thoroughly cleaned, disinfected, and sterilized between procedures to maintain safety and efficacy. Reusable systems require adherence to strict surgical protocols to prevent contamination and ensure sterility, as they are not intended for single-use disposal. The manufacturer specifies its use in sterile surgical environments, emphasizing proper handling and maintenance.
What distinguishes the Vasoshield variant (VH-6001) from the standard model (VH-6000)?
The Vasoshield variant (VH-6001) incorporates additional protective measures during vessel manipulation, which may reduce the risk of vessel damage or complications compared to the standard model (VH-6000). While both systems facilitate endoscopic harvesting, the Vasoshield variant is specifically engineered to enhance safety for delicate tissues, making it a specialized option for procedures where vessel integrity is critical.
How is the regulatory status of this device determined, and what does ‘substantially equivalent’ mean?
The Vasoview Hemopro 3 system holds FDA 510(k) clearance (K233879), meaning it has been deemed ‘substantially equivalent’ to a legally marketed predicate device—an earlier-generation endoscopic harvesting tool. This classification indicates that the device’s intended use, technological characteristics, and performance are comparable to the predicate, ensuring it meets regulatory standards for safety and effectiveness without requiring a full de novo review. The decision was reviewed by the General Plastic Surgery Advisory Committee.
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: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000 ..., Getinge Launches Vasoview Hemopro 3, Advancing Endoscopic Vessel Harvesting
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233879 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
- FDA Applicant
- Maquet Cardiovascular, LLC
Sources (1)
- FDA 510(k) K233879 24 fields · synced Oct 1, 2026