Non-Sterile Broviac Parenteral Alimi-

• • Ongoing Z-1367-2026 FDA Class II ·initiated 12 Dec 2025

  Due to damage to outer tray that can potentially compromise the sterile barrier

510(k) Number

K830256 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Explorer Powered Wheelchair

  Class II

  FDA 510(k) K023485 Active Cleared 2 Dec 2002

• Sterile Hichman/Broviac Injection Cap

  Class II

  FDA 510(k) K840846 Active Cleared 6 Jul 1984

• Steiger Tunneling Instrument 285

  Class II

  FDA 510(k) K840529 Active Cleared 12 Mar 1984

• Galaxy Series Wheelchair

  Class I

  FDA 510(k) K023993 Active Cleared 27 Dec 2002

• Millennium Series Manual Wheelchairs

  Class I

  FDA 510(k) K024030 Active Cleared 12 Dec 2002

• Non-Sterile Peritoneal Access Cathet-

  Class II

  FDA 510(k) K830257 Active Cleared 24 Feb 1983

See all devices from Evermed, Inc. →