PS MEDICAL CATHETER PLACEMENT KIT— 510(k) K940096

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K940096 for PS MEDICAL CATHETER PLACEMENT KIT, Substantially Equivalent on 1994-05-03. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code GWG
Advisory panel: Neurology
Date received: 1994-01-07
Decision date: 1994-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.