CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER— 510(k) K990083

Substantially Equivalent

Sims Deltec, Inc.

FDA 510(k) clearance K990083 for CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER, Substantially Equivalent on 1999-02-12. Applicant: Sims Deltec, Inc..

Clearance details

Applicant: Sims Deltec, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1999-01-11
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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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.