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FDA 510(k)

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

K-Number: K901263 · 1990-08-22

ApplicantNavion Biomedical Corp.
Decision Date1990-08-22
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Navion Biomedical Corp.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K901263. 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 NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM?

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Navion Biomedical Corp.. The 510(k) number is K901263.

When did NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM receive FDA 510(k) clearance?

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM received FDA 510(k) clearance on 1990-08-22, under 510(k) number K901263.

Who is the listed applicant for NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM?

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

What is the FDA product code for NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM?

The FDA product code for NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM 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 Navion Biomedical 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.

K983476BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBESK9730571.4 FR MAPCATH SENSOR STYLETK952626MAPWIRE J-TIP SENSOR GUIDEWIREK940385NAVIGATOR-MP CATHETER LOCATION INSTRUMENT

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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