# K030512: Guidant Vasoview Endoscopic Vessel Harvesting System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: May 14, 2003 after 84 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: 2 generations back to K964171 (1997). 6 ancestors in all.
62 later devices descend from it; 4 cite it directly.
5 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904993: Laparoscopic Electrosurgical Device, Everest Medical Corp. (1991) Summary page 3.
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps, Everest Medical Corp. (1994) Summary page 3.
- K960637: 5MM Endoscope, Origin Medsystems, Inc. (1996) Summary page 3.
- K981700: Vasoview Dissection/Vessel Harvesting System, Origin Medsystems, Inc. (1998) Summary page 3.
- K992353: Blunt Tip Trocar Port, Origin Medsystems, Inc. (1999) Summary page 3.

## Cited in the summary but kept off the family tree
- K974608: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3.

## Most influential descendants
- K060723: 40 L High Flow Insufflator F113 (2006), 45 descendants of its own
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own

## Recalls of this device
- Feb 5, 2009 · Not classified · Z-0614-2011: Sterility may be compromised by a loss of package integrity.

## Indications for use
The Guidant VasoView® 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 patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein or radial artery for use in coronary artery bypass grafting. Thorascopic 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/K030512
Methodology: https://510kreport.com/methodology
