FDA 510(k)

Orbit Infusion Set

K-Number: K150921 · 2016-04-12

Decision Date2016-04-12

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Orbit Infusion Set is a medical device manufactured by Ypsomed AG. It received FDA 510(k) clearance on 2016-04-12 under approval number K150921. 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 Orbit Infusion Set?

Orbit Infusion Set is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by Ypsomed AG. The 510(k) number is K150921.

When was Orbit Infusion Set approved by the FDA?

Orbit Infusion Set received FDA 510(k) clearance on 2016-04-12, under approval number K150921.

What company makes Orbit Infusion Set?

Orbit Infusion Set is manufactured by Ypsomed AG.

What is the FDA product code for Orbit Infusion Set?

The FDA product code for Orbit Infusion Set is FPA.

Other Devices by Ypsomed AG

K171984Clickfine Pen Needle, Penfine Classic Pen Needle K163400Orbit Inserter K243901SmartPilot YpsoMate NS-A2.25

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.