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)

K-Shield Advantage Port Access Infusion Set (PAIS)

K-Number: K190233 · 2019-05-02

ApplicantKawasumi Laboratories, Inc.
Decision Date2019-05-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K-Shield Advantage Port Access Infusion Set (PAIS) is a medical device manufactured by Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2019-05-02 under approval number K190233. 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 K-Shield Advantage Port Access Infusion Set (PAIS)?

K-Shield Advantage Port Access Infusion Set (PAIS) is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Kawasumi Laboratories, Inc.. The 510(k) number is K190233.

When was K-Shield Advantage Port Access Infusion Set (PAIS) approved by the FDA?

K-Shield Advantage Port Access Infusion Set (PAIS) received FDA 510(k) clearance on 2019-05-02, under approval number K190233.

What company makes K-Shield Advantage Port Access Infusion Set (PAIS)?

K-Shield Advantage Port Access Infusion Set (PAIS) is manufactured by Kawasumi Laboratories, Inc..

What is the FDA product code for K-Shield Advantage Port Access Infusion Set (PAIS)?

The FDA product code for K-Shield Advantage Port Access Infusion Set (PAIS) is FPA.

Related Clinical Trials

NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07343986 Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED NCT06951035 Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke RECRUITING NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED NCT05537389 Intravenous Neonatal Central Access Safety Trial RECRUITING

Other Devices by Kawasumi Laboratories, Inc.

K172957Kawasumi Laboratories Blood Drawing Kit (BDK) System K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

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.

↑