K133894 is an FDA 510(k) clearance for the SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on March 18, 2014, 88 days after receiving the submission on December 20, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K133894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2013 |
| Decision Date | March 18, 2014 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |