Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100

• • Terminated Z-0542-2008 FDA Unclassified (pre-2012) ·initiated 8 Aug 2007

  Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.

• • Terminated Z-0132-2008 FDA Unclassified (pre-2012) ·initiated 6 Mar 2007

  Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.

510(k) Number

K061373 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Vnus Vessel and Tissue Coagulation System

  Class II

  FDA 510(k) K033547 Active Cleared 7 Jan 2004

• Modification to Vnus Closure System

  Class II

  FDA 510(k) K003092 Active Cleared 18 Dec 2000

• Vnus Closure System

  Class II

  FDA 510(k) K982816 Active Cleared 17 Mar 1999

• Vnus Closurefast Intravascular Catheter, Models CF7-7-60-2, CF7-7-100-2

  Class II

  FDA 510(k) K082890 Active Cleared 15 Oct 2008

• Vnus Rfs, Model Rfs-6-Xx (Xx = 10, 12, 13, & 15); Vnus Rfs Flex, Model Rfx-6-Xx (Xx = 10, 20, 30 & 40)

  Class II

  FDA 510(k) K052003 Active Cleared 11 Oct 2005

• Vnus Radiofrequency Generator, Model RFG2

  Class II

  FDA 510(k) K040638 Active Cleared 7 Jun 2004

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