SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
FDA 510(k) clearance K133894 · decided 2014-03-18
Clearance details
- K-number
- K133894
- Device name
- SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
- Applicant
- Terumo Europe N.V.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-20
- Decision date
- 2014-03-18
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product C recall (Z-0551-2016) | Terumo Medical Corp | 2015-12-24 |