IPI DUAL LUMEN PORT— 510(k) K934167

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K934167 for IPI DUAL LUMEN PORT, Substantially Equivalent on 1994-07-14. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1993-08-27
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.