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CSF-Cardiac/Peritoneal Catheter

by Pudenz-Schulte Medical Research Corp. 2 variants

510(k) K792005

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792005 Date16 Jan 1980ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0397-2014 FDA Class II initiated 18 Nov 2013

    Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CSF-Cardiac/Peritoneal Catheter is a central nervous system shunt component used for the management of cerebrospinal fluid. It is designed to facilitate the drainage of fluid from the central nervous system to the cardiac or peritoneal regions.

This device is regulated under 21 CFR 882.5550 and has received FDA 510(k) clearance. It is manufactured by Pudenz-Schulte Medical Research Corp. and is classified as a class 2 neurology device.

Other devices from Pudenz-Schulte Medical Research Corp.

See all devices from Pudenz-Schulte Medical Research Corp. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the CSF-Cardiac/Peritoneal Catheter?

    This device is a central nervous system shunt component used for the management of cerebrospinal fluid. It is specifically designed to facilitate the drainage of fluid from the central nervous system to either the cardiac or peritoneal regions.

  • What is the regulatory status of this device?

    The CSF-Cardiac/Peritoneal Catheter is regulated under 21 CFR 882.5550 and has received FDA 510(k) clearance. It is classified as a class 2 neurology device.

  • Who is the manufacturer of this catheter?

    This device is manufactured by Pudenz-Schulte Medical Research Corp., located in McHenry, Illinois.