Vasoview 6 Harvesting Cannula, Model VH-2000; Vasoview 6 Accessory Pack, Model VH-2004

• 2 recalls, same reason

  • Terminated Z-3271-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2009
  • Terminated Z-3270-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2009

  During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.

Full name

Guidant Vasoview 6 Harvesting Cannula, Model Vh-2000; Guidant Vasoview 6 Accessory Pack, Model Vh-2004

510(k) Number

K041981 ↗

FDA Product Code

GEI

Models / Variants

Guidant Vasoview 6 Harvesting Cannula, Model Vh-2000

Guidant Vasoview 6 Accessory Pack, Model Vh-2004

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →

• What is the Vasoview 6 Harvesting Cannula (Model VH-2000) used for?

  The Vasoview 6 Harvesting Cannula (Model VH-2000) is designed for minimally invasive vessel harvesting during surgical procedures, specifically coronary artery bypass grafting. It integrates cutting and coagulation functions to provide controlled access and precision, minimizing tissue trauma and enhancing procedural efficiency.

• How is the Vasoview 6 system supplied, and is it reusable?

  The Vasoview 6 system, including the Harvesting Cannula (Model VH-2000) and Accessory Pack (Model VH-2004), is supplied as a sterile, single-use device. This ensures patient safety and maintains device integrity for one-time surgical use only.

• What storage conditions are required to maintain sterility and functionality?

  To preserve sterility and functionality, the Vasoview 6 system must be stored under proper conditions as specified by the manufacturer. This typically includes keeping the device in its original packaging, away from direct sunlight, extreme temperatures, and moisture, until ready for use.

• Does the Vasoview 6 system have any specific MRI safety information?

  No specific MRI safety information is provided for the Vasoview 6 Harvesting Cannula or its accessory pack. Clinicians should follow standard MRI safety protocols and consult manufacturer guidelines before using the device in an MRI environment.

• What regulatory clearance does the Vasoview 6 Harvesting Cannula hold?

  The Vasoview 6 Harvesting Cannula (Model VH-2000) and its accessory pack (Model VH-2004) have received FDA 510(k) clearance under Special Controls for General, Plastic Surgery applications. This clearance confirms the device meets regulatory standards for its intended use.