Butterfly Non-Coring Needle Set

• • Terminated Z-0098-04 FDA Unclassified (pre-2012) ·initiated 23 Sep 2003

  Sterility of product is compromised by open seals in packaging.

510(k) Number

K863606 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cormed II Ambulatory Infusion Pump

  Class II

  FDA 510(k) K850674 Active Cleared 9 Apr 1985

• Sterile Cormed Mediport

  Class II

  FDA 510(k) K850967 Active Cleared 17 May 1985

• Corcath H & B Vascular Access Catheter

  Class II

  FDA 510(k) K823553 Active Cleared 5 Jan 1983

• Port-Gard

  Class II

  FDA 510(k) K854019 Active Cleared 26 Nov 1985

• Cormed Huber Point Needle

  Class I

  FDA 510(k) K843083 Active Cleared 5 Sep 1984

• Percutaneous Introducer Kit

  Class II

  FDA 510(k) K860432 Active Cleared 31 Mar 1986

See all devices from Cormed, Inc., Sub. C.R.Bard, Inc. →