SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

Set, Administration, Intravascular

TERUMO EUROPE N.V.

The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Surflo Winged Infusion Set With Needle Protection (surshield).

Pre-market Notification Details

• Device ID: K133867
• 510k Number: K133867
• Device Name: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
• Classification: Set, Administration, Intravascular
• Applicant: TERUMO EUROPE N.V. INTERLEUVENLAAN 40 Leuven, BE 3001
• Contact: M.j. Aerts
• Correspondent: M.j. Aerts; TERUMO EUROPE N.V. INTERLEUVENLAAN 40 Leuven, BE 3001
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-20
• Decision Date: 2014-02-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
55413206055918	K133867	000
55413206055901	K133867	000
55413206054904	K133867	000
55413206054881	K133867	000
35413206246206	K133867	000