FDA 510(k)

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)

K-Number: K974829 · 1998-02-12

ApplicantKawasumi Laboratories Co., Ltd.

Decision Date1998-02-12

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974829. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)?

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K974829.

When did NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) receive FDA 510(k) clearance?

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974829.

Who is the listed applicant for NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)?

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

What is the FDA product code for NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)?

The FDA product code for NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) is LJT.

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Other records listing Kawasumi Laboratories Co., Ltd. as applicant

K994323KAWASUMI LABORATORIES PHILEBOTOMY SET K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER K935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION K930012KAWASUMI LABORATORIES K-CUFF

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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.