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Csf-Cardiac/Peritoneal Catheter

by Pudenz-Schulte Medical Research Corp. 2 variants

510(k) K871752

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK871752 Date22 May 1987ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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, 6 Oct 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 shunt, central nervous system and components device. It is used in the field of neurology. The device is classified as a class 2 device.

The Csf-Cardiac/Peritoneal Catheter is supplied by Pudenz-Schulte Medical Research Corp. It is regulated under 21 CFR 882.5550 and has the product code JXG. The device has been cleared by the FDA with the k number K871752, with a decision date of May 22, 1987.

Other devices from Pudenz-Schulte Medical Research Corp.

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

Questions

AI-generated answers, 6 Oct 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 CSF-Cardiac/Peritoneal Catheter used for?

    This device is a shunt for the central nervous system, designed for use in the field of neurology. It functions as a catheter to manage cerebrospinal fluid (CSF) by diverting it either to the cardiac or peritoneal cavity.

  • Who manufactures this catheter?

    The CSF-Cardiac/Peritoneal Catheter is manufactured and supplied by Pudenz-Schulte Medical Research Corp., a company based in Goleta, California, USA.

  • What is the regulatory classification of this device?

    It is classified as a Class II medical device under 21 CFR 882.5550 with the FDA product code JXG. It was cleared via the traditional 510(k) premarket notification process.

  • When was this device cleared by the FDA?

    The device received FDA clearance under K-number K871752, with a decision date of May 22, 1987, following a submission received on May 8, 1987.

  • Is this device associated with any specific medical specialty?

    Yes, the device is associated with the neurology specialty, as indicated by its review advisory committee designation and its clinical application in managing cerebrospinal fluid dynamics.