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FDA 510(k)

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING

K-Number: K100720 · 2010-11-18

ApplicantKawasumi Laboratories, Inc.
Decision Date2010-11-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING 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 2010-11-18 under 510(k) number K100720. 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 PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING?

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K100720.

When did K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING receive FDA 510(k) clearance?

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING received FDA 510(k) clearance on 2010-11-18, under 510(k) number K100720.

Who is the listed applicant for K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING?

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 PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING?

The FDA product code for K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING is FPA.

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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)K190233K-Shield Advantage Port Access Infusion Set (PAIS)K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemK123344K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTORK073257KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR

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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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure 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)

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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