KENDALL ULTRAMER COUDE FOLEY CATHETER - Model 6946C

• • Ongoing Z-1050-2024 FDA Class I ·initiated 4 Dec 2023

  Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

510(k) Number

K990500 ↗

FDA Product Code

EZL

Models / Variants

1416C

Kendall Curity Coude Foley Catheter Tray

Model 6946C

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Curity Venous Catheterization Kit

  Class II

  FDA 510(k) K861828 Active Cleared 10 Jul 1986

• Curity Fiberoptic Intubating Airway

  Class I

  FDA 510(k) K855137 Active Cleared 11 Mar 1986

• Curity Curad Bandages

  Class I

  FDA 510(k) K810126 Active Cleared 6 Feb 1981

• The Kendall Urinary Output Monitor

  Class I

  FDA 510(k) K852083 Active Cleared 20 Sep 1985

• Kendall Curity Irrigation Syringe

  Class II

  FDA 510(k) K892436 Active Cleared 14 Jul 1989

• Curity Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K871066 Active Cleared 15 May 1987

See all devices from The Kendal Co. →