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)

IV Administration Sets

K-Number: K202618 · 2021-09-24

ApplicantB.Braun Medical, Inc.
Decision Date2021-09-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV Administration Sets is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2021-09-24 under approval number K202618. 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 IV Administration Sets?

IV Administration Sets is a medical device that received FDA 510(k) clearance on 2021-09-24. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K202618.

When was IV Administration Sets approved by the FDA?

IV Administration Sets received FDA 510(k) clearance on 2021-09-24, under approval number K202618.

What company makes IV Administration Sets?

IV Administration Sets is manufactured by B.Braun Medical, Inc..

What is the FDA product code for IV Administration Sets?

The FDA product code for IV Administration Sets is FPA.

Other Devices by B.Braun Medical, Inc.

K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL K153297Perifix and Contiplex Catheter K153293Extension Set K151423APEX Compounding System Transfer Set K151772Actreen Mini Intermittent Urinary Catheters K171584B. Braun Tear-Away Introducer Needle

View all 34 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.

↑