FDA 510(k)

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

K-Number: K030385 · 2003-04-15

ApplicantKawasumi Laboratories America, Inc.

Decision Date2003-04-15

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories America, Inc.. It received FDA 510(k) clearance on 2003-04-15 under 510(k) number K030385. 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 ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR?

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR is a medical device that received FDA 510(k) clearance on 2003-04-15. The listed applicant is Kawasumi Laboratories America, Inc.. The 510(k) number is K030385.

When did IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR receive FDA 510(k) clearance?

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR received FDA 510(k) clearance on 2003-04-15, under 510(k) number K030385.

Who is the listed applicant for IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR?

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

What is the FDA product code for IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR?

The FDA product code for IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR is FPA.

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Other records listing Kawasumi Laboratories America, Inc. as applicant

K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)K001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD K001043KAWASUMI LABORATORY BLOOD DRAWING KIT

Related Devices (Code: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.