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FDA 510(k)

TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

K-Number: K000665 · 2000-05-02

ApplicantTfx Medical, Inc.
Decision Date2000-05-02
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Tfx Medical, Inc.. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000665. 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 TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Tfx Medical, Inc.. The 510(k) number is K000665.

When did TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER receive FDA 510(k) clearance?

TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000665.

Who is the listed applicant for TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

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

What is the FDA product code for TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

The FDA product code for TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER 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 Tfx Medical, 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.

K021034MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK020985MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK993191TFX MEDICAL INTRODUCER ASSEMBLY

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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