Rusch Blakemore 3 Lumen, Sterile

• • Terminated Z-1506-2014 FDA Class II ·initiated 4 Mar 2014

  Sterility of the product cannot be guaranteed.

510(k) Number

K981203 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Epidural Catheter Models 1210/1200

  Class II

  FDA 510(k) K983125 Active Cleared 17 Nov 1998

• Flocath

  Class II

  FDA 510(k) K000070 Active Cleared 18 Feb 2000

• Intermittent Urethral Catheters

  Class II

  FDA 510(k) K033023 Active Cleared 23 Dec 2003

• Rusch Miller-Abbott Tube

  Class II

  FDA 510(k) K010797 Active Cleared 26 Feb 2002

• Rusch Floneil; Flocath Introgel

  Class II

  FDA 510(k) K020714 Active Cleared 1 Jul 2002

• Rusch Schroeder Endotracheal Tube Style

  Class I

  FDA 510(k) K955238 Active Cleared 6 Feb 1996

See all devices from Rusch Intl. →