Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BD FlowSmart Set, MiniMed Pro-Set

K-Number: K160651 · 2016-04-07

ApplicantBecton, Dickinson and Company
Decision Date2016-04-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD FlowSmart Set, MiniMed Pro-Set is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-04-07 under approval number K160651. 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 BD FlowSmart Set, MiniMed Pro-Set?

BD FlowSmart Set, MiniMed Pro-Set is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K160651.

When was BD FlowSmart Set, MiniMed Pro-Set approved by the FDA?

BD FlowSmart Set, MiniMed Pro-Set received FDA 510(k) clearance on 2016-04-07, under approval number K160651.

What company makes BD FlowSmart Set, MiniMed Pro-Set?

BD FlowSmart Set, MiniMed Pro-Set is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD FlowSmart Set, MiniMed Pro-Set?

The FDA product code for BD FlowSmart Set, MiniMed Pro-Set is FPA.

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

View all 100 devices →

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.

↑