Surflo Winged Infusion Set
K-Number: K221411 · 2023-06-23
Decision Date2023-06-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Surflo Winged Infusion Set is a medical device manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-06-23 under approval number K221411. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surflo Winged Infusion Set?
Surflo Winged Infusion Set is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K221411.
When was Surflo Winged Infusion Set approved by the FDA?
Surflo Winged Infusion Set received FDA 510(k) clearance on 2023-06-23, under approval number K221411.
What company makes Surflo Winged Infusion Set?
Surflo Winged Infusion Set is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd..
What is the FDA product code for Surflo Winged Infusion Set?
The FDA product code for Surflo Winged Infusion Set is FPA.
Other Devices by Terumo Medical Products (Hangzhou) Co., Ltd.
Related Devices (Code: FPA)
K160007Paclitaxel SetsBaxter Healthcare Corporation
K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc.
K161323Solution Set for Epidural UseBaxter Healthcare Corporation
K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC
K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.
K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.