# K052274: Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Sep 21, 2005 after 30 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945975 (1994). 11 ancestors in all.
7 later devices descend from it; 3 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030512: Guidant Vasoview Endoscopic Vessel Harvesting System, Guidant Corp. (2003)
- K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004, Guidant Corporation (2004)

## Most influential descendants
- K101274: Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (2010), 4 descendants of its own
- K233879: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (2024), 2 descendants of its own
- K153194: VASOVIEW HemoPro Endoscopic Vessel Harvesting System (2016), 1 descendant of its own
- K251238: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (2025), 0 descendants of its own
- K243918: Vasoview Hemopro 3 Power Supply (2025), 0 descendants of its own

## Recalls of this device
- Sep 20, 2024 · Class I · Z-0092-2025: There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
- Dec 1, 2023 · Class II · Z-0723-2024: Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for pati
- Oct 30, 2013 · Class II · Z-0466-2014: Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
- Dec 17, 2009 · Not classified · Z-3272-2011: During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.

## Indications for use
The VasoView® HemoProTM System 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 or 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 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.

Source page: https://510kreport.com/device/K052274
Methodology: https://510kreport.com/methodology