Rusch Urodynamic Rectal Balloon 2-Way Catheter

• • Terminated Z-1368-2018 FDA Class II ·initiated 15 Mar 2018

  These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

510(k) Number

K962472 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

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. →