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FDA 510(k)

ALARIS SAFETY MALE LUER

K-Number: K053049 · 2006-01-12

ApplicantCardinal Health, Alaris Products
Decision Date2006-01-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALARIS SAFETY MALE LUER is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2006-01-12 under 510(k) number K053049. 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 ALARIS SAFETY MALE LUER?

ALARIS SAFETY MALE LUER is a medical device that received FDA 510(k) clearance on 2006-01-12. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K053049.

When did ALARIS SAFETY MALE LUER receive FDA 510(k) clearance?

ALARIS SAFETY MALE LUER received FDA 510(k) clearance on 2006-01-12, under 510(k) number K053049.

Who is the listed applicant for ALARIS SAFETY MALE LUER?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALARIS SAFETY MALE LUER?

The FDA product code for ALARIS SAFETY MALE LUER 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardinal Health, Alaris Products 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.

K071400SMARTSITE STOPCOCKK071108TEXIUM SYRINGEK061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSK052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDK051641ALARIS SYSTEM PC UNIT, MODEL 8001K050115BLOOD HAND PUMP ADMINISTRATION SET

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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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