SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)— 510(k) K072894
Substantially EquivalentTerumo Europe N.V.
FDA 510(k) clearance K072894 for SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), Substantially Equivalent on 2007-11-06. Applicant: Terumo Europe N.V.. Device class: 2.
Clearance details
- Applicant
- Terumo Europe N.V.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Leuven, BE
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Terumo Europe N.V.
view allAdverse 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, through . 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.