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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 the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) 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. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K190233.

When did K-Shield Advantage Port Access Infusion Set (PAIS) receive FDA 510(k) clearance?

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

Who is the listed applicant for K-Shield Advantage Port Access Infusion Set (PAIS)?

The FDA 510(k) record lists Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02633124Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.TERMINATED

Other records listing Kawasumi Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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.

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