Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002
by Guidant Corporation, Cardiac Surgery
510(k) K022718
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022718 | Date28 Aug 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vasoview 6 Harvesting Cannula is a minimally invasive surgical device designed for vessel harvesting procedures. It facilitates access to vessels while enabling cutting and coagulation of tissue, supporting coronary artery bypass grafting. The cannula is intended for use in endoscopic surgery to harvest arterial grafts with reduced trauma. Its design supports precise dissection and haemostasis during minimally invasive procedures.
The device is supplied as a reusable surgical instrument and is classified under FDA 510(k) clearance as substantially equivalent to existing products. Models VH-2000, VH-2001, and VH-2002 are intended for general and plastic surgery applications. Sterility and MRI safety are not specified in the regulatory data. Storage and handling instructions are not provided, but standard surgical instrument protocols apply. The device holds an FDA 510(k) clearance (K022718) under traditional review.
Other devices from Guidant Corporation, Cardiac Surgery
Questions
AI-generated answers, 1 Oct 2026
What is the Vasoview 6 Harvesting Cannula used for?
The Vasoview 6 Harvesting Cannula is designed for vessel harvesting procedures in endoscopic surgery, specifically to support coronary artery bypass grafting (CABG). Its primary function is to provide access to vessels while enabling cutting and coagulation of tissue, reducing trauma during dissection. This makes it ideal for minimally invasive harvesting of arterial grafts.
Are the Vasoview 6 models reusable or single-use?
The Vasoview 6 Harvesting Cannula (models VH-2000, VH-2001, and VH-2002) is supplied as a reusable surgical instrument. Reusability is common for endoscopic harvesting tools to balance cost, sterility protocols, and durability for repeated surgical use. Always follow standard surgical instrument reprocessing guidelines to ensure safety and functionality.
What are the key differences between the VH-2000, VH-2001, and VH-2002 models?
The regulatory data does not specify detailed technical differences between the VH-2000, VH-2001, and VH-2002 models beyond their classification under the same product code (GEI) for general and plastic surgery applications. These models are likely designed for similar procedural purposes but may vary in minor features like tip design, length, or ergonomics. For precise distinctions, consult the manufacturer’s technical documentation or contact Guidant Corporation.
How should the Vasoview 6 Harvesting Cannula be stored?
The regulatory data does not provide specific storage instructions for the Vasoview 6 Harvesting Cannula. However, as a reusable surgical instrument, it should be stored in a clean, dry environment following standard surgical instrument protocols. This typically includes protection from moisture, dust, and physical damage to maintain sterility and functionality until reprocessing.
What regulatory approval does the Vasoview 6 Harvesting Cannula hold?
The Vasoview 6 Harvesting Cannula holds an FDA 510(k) clearance (K022718) under traditional review, classified as substantially equivalent to existing products. This clearance was granted in 2002 for use in general and plastic surgery applications, specifically for vessel harvesting procedures. The device was reviewed by the Surgical and Urological Devices Advisory Committee (SU).