# K140008: Virtuosaph Plus Endoscopic Vessel Harvesting System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Oct 31, 2014 after 302 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945975 (1994). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092789: Virtuosaph Plus Endoscopic Vessel Harvesting System, Terumo Cardiovascular Systems Corp. (2010) Summary page 4.
- K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004, Guidant Corporation (2004) Summary page 4.

## Most influential descendants
- K160206: VirtuoSaph Plus Endoscopic Vessel Harvesting System (2016), 0 descendants of its own

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0227-2019: The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed 

## Indications for use
The VirtuoSaph® Plus Endoscopic Vessel Harvesting 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 and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

Source page: https://510kreport.com/device/K140008
Methodology: https://510kreport.com/methodology