ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS— 510(k) K120872

Substantially Equivalent

Unomedical A/S Infusion Devices

FDA 510(k) clearance K120872 for ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS, Substantially Equivalent on 2012-04-20. Applicant: Unomedical A/S Infusion Devices.

Clearance details

Applicant: Unomedical A/S Infusion Devices
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2012-03-22
Decision date: 2012-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Osted, DK

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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.