Solution Set for Epidural Use
K-Number: K161323 · 2016-11-30
ApplicantBaxter Healthcare Corporation
Decision Date2016-11-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Solution Set for Epidural Use is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2016-11-30 under approval number K161323. 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 Solution Set for Epidural Use?
Solution Set for Epidural Use is a medical device that received FDA 510(k) clearance on 2016-11-30. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K161323.
When was Solution Set for Epidural Use approved by the FDA?
Solution Set for Epidural Use received FDA 510(k) clearance on 2016-11-30, under approval number K161323.
What company makes Solution Set for Epidural Use?
Solution Set for Epidural Use is manufactured by Baxter Healthcare Corporation.
What is the FDA product code for Solution Set for Epidural Use?
The FDA product code for Solution Set for Epidural Use is FPA.
Related Clinical Trials
Other Devices by Baxter Healthcare Corporation
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.
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
K151250Smart SetTop Spins, Inc.
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.