P-S CSF-VENTRICULAR CATHETER, FLANGED— 510(k) K823503

Name: FDA 510(k) clearance K823503
Creator: U.S. Food and Drug Administration
Published: 1983-03-09

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K823503 for P-S CSF-VENTRICULAR CATHETER, FLANGED, Substantially Equivalent on 1983-03-09. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 2.

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 1982-11-24
Decision date: 1983-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT1995-09-18
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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.