FDA 510(k)

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)

K-Number: K102890 · 2010-10-21

ApplicantKawasumi Laboratories America, Inc.

Decision Date2010-10-21

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) 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 2010-10-21 under 510(k) number K102890. 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 SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)?

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) is a medical device that received FDA 510(k) clearance on 2010-10-21. The listed applicant is Kawasumi Laboratories America, Inc.. The 510(k) number is K102890.

When did K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) receive FDA 510(k) clearance?

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) received FDA 510(k) clearance on 2010-10-21, under 510(k) number K102890.

Who is the listed applicant for K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)?

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 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)?

The FDA product code for K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kawasumi Laboratories America, Inc. as applicant

K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR 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

View on FDA Database →

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