The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Surflo Winged Infusion Set With Filter And Needle Protection (surshield).
| Device ID | K070547 |
| 510k Number | K070547 |
| Device Name: | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) |
| Classification | Set, Administration, Intravascular |
| Applicant | TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven, BE 3001 |
| Contact | M.j. Aerts |
| Correspondent | M.j. Aerts TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven, BE 3001 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-05-25 |
| Summary: | summary |