CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300— 510(k) K982839

Substantially Equivalent

Sims Deltec, Inc.

FDA 510(k) clearance K982839 for CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300, Substantially Equivalent on 1998-11-02. Applicant: Sims Deltec, Inc..

Clearance details

Applicant: Sims Deltec, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 1998-08-12
Decision date: 1998-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.