# K092789: Virtuosaph Plus Endoscopic Vessel Harvesting System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: May 12, 2010 after 244 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 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). 13 ancestors in all.
2 later devices descend 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)
- K083194: Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550, Terumo Cardiovascular Systems Corp. (2009) Summary page 2.
- K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004, Guidant Corporation (2004) Summary page 2.

## Most influential descendants
- 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
- Dec 12, 2013 · Class II · Z-1069-2014: Sterility of medical devices intended for use in surgical procedures may be compromised.
- Jun 10, 2011 · Not classified · Z-2854-2011: Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cas

## Indications for use
The VirtuoSaph TM Plus Endloscopic 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.

Source page: https://510kreport.com/device/K092789
Methodology: https://510kreport.com/methodology