SAFETY INJECTION PORT— 510(k) K903541

Substantially Equivalent

Du-Call Miller Plastics, Inc.

FDA 510(k) clearance K903541 for SAFETY INJECTION PORT, Substantially Equivalent on 1990-09-14. Applicant: Du-Call Miller Plastics, Inc..

Clearance details

Applicant: Du-Call Miller Plastics, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1990-08-07
Decision date: 1990-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.