PVC FREE INTRAVASCULAR ADMINISTRATION SET— 510(k) K011216

Substantially Equivalent

Biometrix , Ltd.

FDA 510(k) clearance K011216 for PVC FREE INTRAVASCULAR ADMINISTRATION SET, Substantially Equivalent on 2001-07-18. Applicant: Biometrix , Ltd..

Clearance details

Applicant: Biometrix , Ltd.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-04-20
Decision date: 2001-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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.