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FDA 510(k)

MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER

K-Number: K130518 · 2013-04-30

ApplicantLuther Needlesafe Products, Inc.
Decision Date2013-04-30
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER 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 2013-04-30 under 510(k) number K130518. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER?

MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER is a medical device that received FDA 510(k) clearance on 2013-04-30. The listed applicant is Luther Needlesafe Products, Inc.. The 510(k) number is K130518.

When did MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER receive FDA 510(k) clearance?

MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER received FDA 510(k) clearance on 2013-04-30, under 510(k) number K130518.

Who is the listed applicant for MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER?

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 MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER?

The FDA product code for MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER is FOZ.

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.

K040527LOW PROFILE LUTHER SAFETY HUBER

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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