SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)— 510(k) K133894
Substantially EquivalentTerumo Europe N.V.
FDA 510(k) clearance K133894 for SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD), Substantially Equivalent on 2014-03-18. 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
- Traditional
- Location
- Leuven, BE
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
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- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- 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 →
Recalls naming K133894
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133894.
Data sourced from openFDA. This site is unofficial and independent of the FDA.