PENTADEFLUE IV SOLUTION ADMINISTRATION SETS— 510(k) K041495

Substantially Equivalent

Pentaferte S.P.A

FDA 510(k) clearance K041495 for PENTADEFLUE IV SOLUTION ADMINISTRATION SETS, Substantially Equivalent on 2005-04-15. Applicant: Pentaferte S.P.A.

Clearance details

Applicant: Pentaferte S.P.A
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2004-06-04
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Campli (Teramo), IT

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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.