Manufacturer
Maquet Cardiovascular, LLCVasoview Hemopro 3 Power Supply
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243918
- Device name
- Vasoview Hemopro 3 Power Supply
- Company
- Maquet Cardiovascular, LLC
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-12-20
- Decision date
- 2025-02-26
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryTissue RepairPain Management
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, which is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Intended Use
The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, which is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Device Description
The Vasoview Hemopro 3 Power Supply is a reusable, AC-powered device intended to be used only with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. The Vasoview Hemopro 3 Power Supply provides DC current to the Vasoview Hemopro 3 Harvesting Tool to enable cutting and coagulation of vessels and tissue during vessel harvesting procedures. The Vasoview Hemopro 3 Power Supply is positioned outside the sterile field, and can be placed on a flat, non-sterile surface or may be suspended from a nearby IV pole. The Vasoview Hemopro 3 Power Supply does not make contact with the patient, nor does it deliver energy directly to the patient; energy to the patient is delivered by the Vasoview Hemopro 3 Harvesting Tool. The Vasoview Hemopro 3 Power Supply is intended to be used by healthcare professionals in an operating room environment. Principles of Operation: The Vasoview Hemopro 3 Power Supply is connected to AC power via a hospital grade power cord and features an on/off switch and green power-on LED indicator. DC output power is delivered to the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System when the Vasoview Hemopro 3 Harvesting Tool Activation Toggle is activated. The Vasoview Hemopro 3 Power Supply does not produce RF energy. When activated, an energy-regulating circuit within the Vasoview Hemopro 3 Power Supply controls the energy delivery to the Vasoview Hemopro 3 Harvesting Tool to perform its cut/coagulation cycle.
Summary parsed at:2026-06-20 17:54:13 UTC
