SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)— 510(k) K070547

Substantially Equivalent

Terumo Europe N.V.

FDA 510(k) clearance K070547 for SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD), Substantially Equivalent on 2007-05-25. Applicant: Terumo Europe N.V..

Clearance details

Applicant: Terumo Europe N.V.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2007-02-26
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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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.