H-H Slotted Ventricular Catheter

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

510(k) Number

K791076 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• H-H Alimentation Catheters

  Class II

  FDA 510(k) K821012 Active Cleared 28 May 1982

• H-H Fixation & Joining Connectors

  Class II

  FDA 510(k) K853369 Active Cleared 11 Sep 1985

• H-H Burr Hole Catheter Support

  Class II

  FDA 510(k) K820311 Active Cleared 24 Feb 1982

• H-H Hunter Active Tendon Implant Pc

  Class II

  FDA 510(k) K872284 Active Cleared 28 Sep 1987

• H-H Fixation and Joining Connectors

  Class II

  FDA 510(k) K790849 Active Cleared 11 May 1979

• Valve, H-H Cruciform Slit

  Class II

  FDA 510(k) K790126 Active Cleared 26 Jan 1979

See all devices from Holter-Hausner Intl. →

• What is the primary clinical purpose of the H-H Slotted Ventricular Catheter, and how does its design support that purpose?

  The H-H Slotted Ventricular Catheter is designed for cerebrospinal fluid (CSF) drainage within the ventricular system of the brain, primarily used in the management of hydrocephalus. Its slotted tubing facilitates fluid flow while maintaining patency, ensuring effective CSF drainage to alleviate pressure buildup in the brain.

• Is the H-H Slotted Ventricular Catheter intended for reuse, or is it meant to be used only once?

  The H-H Slotted Ventricular Catheter is explicitly intended for single-use only, as stated in its description. This ensures patient safety and sterility, as it is supplied sterile and not designed for repeated use.

• What regulatory pathway was followed for the FDA clearance of this device, and which committee was involved?

  The H-H Slotted Ventricular Catheter received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent to a predicate device. The review was conducted under the Neurology advisory committee (NE), reflecting its classification as a Class II medical device under 21 CFR 882.5550.

• Are there any specific storage instructions or considerations for handling the H-H Slotted Ventricular Catheter before use?

  While the provided data does not detail explicit storage instructions, the catheter is supplied sterile and intended for single-use. Standard sterile medical device handling practices—such as protecting from contamination, avoiding exposure to extreme temperatures, and adhering to manufacturer guidelines—should be followed to maintain integrity until use.