K070430

Substantially Equivalent

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

Applicant: Unomedical A/S
Product code: FPA
Advisory panel: General Hospital
Date received: 2007-02-13
Decision date: 2007-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roskilde, DK

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.