H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007

• • Terminated Z-2570-2014 FDA Class II ·initiated 3 Jul 2014

  Unsealed pouches.

510(k) Number

K020951 ↗

FDA Product Code

LKF

Models / Variants

H/S Catheter Set (5F), Model 61-5005

H/S Catheter Set (7F), Model 61-5007

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Ackrad Endotracheal Tube Introducing Guide

  Class I

  FDA 510(k) K844557 Active Cleared 17 Dec 1984

• Nicos (Non-Invasive Cardiac Output System)

  Class I

  FDA 510(k) K904499 Active Cleared 1 Jul 1991

• Ackrad Bronchitrac

  Class I

  FDA 510(k) K822398 Active Cleared 4 Oct 1982

• Modified Infant Nasal Cannulae Assembly

  Class II

  FDA 510(k) K895031 Active Cleared 30 Oct 1989

• Ackrad Hysterosalpingography Set

  Class II

  FDA 510(k) K842231 Active Cleared 19 Sep 1984

• N-D0-Sure

  Class I

  FDA 510(k) K811185 Active Cleared 2 Jun 1981

See all devices from Ackrad Laboratories →