K042129

Substantially Equivalent

F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK

Applicant: Cedic S.R.L.
Product code: FPA
Advisory panel: General Hospital
Date received: 2004-08-06
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peschiera Borromeo, IT

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.