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FDA 510(k)

LOW PROFILE LUTHER SAFETY HUBER

K-Number: K040527 · 2004-03-26

ApplicantLuther Needlesafe Products, Inc.
Decision Date2004-03-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE LUTHER SAFETY HUBER is the device name listed in this FDA 510(k) record. The listed applicant is Luther Needlesafe Products, Inc.. It received FDA 510(k) clearance on 2004-03-26 under 510(k) number K040527. 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 LOW PROFILE LUTHER SAFETY HUBER?

LOW PROFILE LUTHER SAFETY HUBER is a medical device that received FDA 510(k) clearance on 2004-03-26. The listed applicant is Luther Needlesafe Products, Inc.. The 510(k) number is K040527.

When did LOW PROFILE LUTHER SAFETY HUBER receive FDA 510(k) clearance?

LOW PROFILE LUTHER SAFETY HUBER received FDA 510(k) clearance on 2004-03-26, under 510(k) number K040527.

Who is the listed applicant for LOW PROFILE LUTHER SAFETY HUBER?

The FDA 510(k) record lists Luther Needlesafe Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW PROFILE LUTHER SAFETY HUBER?

The FDA product code for LOW PROFILE LUTHER SAFETY HUBER 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 Luther Needlesafe Products, 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.

K130518MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER

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

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

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