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VASOVIEW 6 HARVESTING CANNULA - Vh-2000

by Guidant Corporation, Cardiac Surgery

510(k) K022718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022718 Date28 Aug 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Models / Variants
Vh-2000
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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).