# K083194: Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jan 16, 2009 after 79 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 3 generations back to K964171 (1997). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031891: Virtuosaph, Terumo Cardiovascular Systems Corp. (2003) Summary page 2.

## Most influential descendants
- K092789: Virtuosaph Plus Endoscopic Vessel Harvesting System (2010), 2 descendants of its own
- K140008: Virtuosaph Plus Endoscopic Vessel Harvesting System (2014), 1 descendant of its own
- K160206: VirtuoSaph Plus Endoscopic Vessel Harvesting System (2016), 0 descendants of its own

## Recalls of this device
- Jan 10, 2011 · Not classified · Z-1230-2011: The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar 

## Indications for use
VirtuoSaphTM Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting

Source page: https://510kreport.com/device/K083194
Methodology: https://510kreport.com/methodology