H/S Catheter Set(61-3005, 61-3007, 61-3605, 61-3607)

• • Ongoing Z-1613-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• • Ongoing Z-0502-2024 FDA Class II ·initiated 31 Mar 2022

  Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

510(k) Number

K961752 ↗

FDA Product Code

LKF

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 →