510(k) Report

Devices descending from K031266

7 later devices reach Surshield Safety Winged Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072894Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20073—
+1K052887Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VSTerumo Europe N.V.20056—
+2K133867Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20140—
+2K100946Intravscular Administration SetTerumo Europe N.V.20102—
+2K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V.20074—
+3K140175Intravascular Administration SetDelta Med Spa20140—
+3K133894Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V.201401