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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953034 ↗

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 →

• What is the H/S Catheter Set used for in obstetrics and gynecology?

  The H/S Catheter Set is designed for diagnostic and therapeutic procedures in obstetrics and gynecology, specifically to facilitate the insertion of contrast media or instruments into the uterine cavity. This aids in procedures like hysterosalpingography (HSG) or uterine cavity assessment, ensuring accurate visualization and intervention.

• How is the H/S Catheter Set supplied, and is it reusable?

  The H/S Catheter Set is supplied as a sterile, single-use device. Each model (61-3005, 61-3007, 61-3605, 61-3607) comes individually packaged to maintain sterility and prevent cross-contamination. Single-use ensures patient safety and compliance with clinical best practices.

• Are there different sizes or models available, and what distinguishes them?

  Yes, the H/S Catheter Set includes four distinct models: 61-3005, 61-3007, 61-3605, and 61-3607. While the exact distinctions between these models are not specified in the data, they are likely differentiated by catheter length, tip design, or other functional features to accommodate varying clinical needs in uterine procedures.

• Can the H/S Catheter Set be used in MRI environments?

  Some models of the H/S Catheter Set are designed to be MRI-compatible, as noted in the manufacturer’s guidelines. This compatibility ensures safe use in MRI environments where imaging is required during or after the procedure, reducing the need for additional transfers or repositioning of the patient.

• How should the H/S Catheter Set be stored to maintain sterility and functionality?

  The H/S Catheter Set must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the individually sealed, sterile packaging intact in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow the instructions provided with the device to ensure optimal performance.