SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER— 510(k) K113429

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K113429 for SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER, Substantially Equivalent on 2012-03-12. Applicant: Nipro Medical Corporation.

Clearance details

Applicant: Nipro Medical Corporation
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2011-11-21
Decision date: 2012-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.