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FDA 510(k)

MEDISYSTEMS LUER ACCESS INJECTION SITE

K-Number: K010279 · 2001-05-29

ApplicantMedisystems Corp.
Decision Date2001-05-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEMS LUER ACCESS INJECTION SITE is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K010279. 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 MEDISYSTEMS LUER ACCESS INJECTION SITE?

MEDISYSTEMS LUER ACCESS INJECTION SITE is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Medisystems Corp.. The 510(k) number is K010279.

When did MEDISYSTEMS LUER ACCESS INJECTION SITE receive FDA 510(k) clearance?

MEDISYSTEMS LUER ACCESS INJECTION SITE received FDA 510(k) clearance on 2001-05-29, under 510(k) number K010279.

Who is the listed applicant for MEDISYSTEMS LUER ACCESS INJECTION SITE?

The FDA 510(k) record lists Medisystems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISYSTEMS LUER ACCESS INJECTION SITE?

The FDA product code for MEDISYSTEMS LUER ACCESS INJECTION SITE is FPA.

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Other records listing Medisystems Corp. 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.

K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEK002372ACCESS ALERT GAUGEK994306REVERSOK990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSK983076MEDISYSTEMS TRANSDUCER PROTECTORK971860MEDISYSTEMS DIALYSIS PRIMING SETS

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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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