CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP— 510(k) K013714

Substantially Equivalent

Codan US Corp.

FDA 510(k) clearance K013714 for CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP, Substantially Equivalent on 2002-03-28. Applicant: Codan US Corp..

Clearance details

Applicant: Codan US Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-11-08
Decision date: 2002-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.