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FDA 510(k)

NAVIGATOR-MP CATHETER LOCATION INSTRUMENT

K-Number: K940385 · 1994-06-02

ApplicantNavion Biomedical Corp.
Decision Date1994-06-02
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR-MP CATHETER LOCATION INSTRUMENT 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 1994-06-02 under 510(k) number K940385. 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 NAVIGATOR-MP CATHETER LOCATION INSTRUMENT?

NAVIGATOR-MP CATHETER LOCATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Navion Biomedical Corp.. The 510(k) number is K940385.

When did NAVIGATOR-MP CATHETER LOCATION INSTRUMENT receive FDA 510(k) clearance?

NAVIGATOR-MP CATHETER LOCATION INSTRUMENT received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940385.

Who is the listed applicant for NAVIGATOR-MP CATHETER LOCATION INSTRUMENT?

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 NAVIGATOR-MP CATHETER LOCATION INSTRUMENT?

The FDA product code for NAVIGATOR-MP CATHETER LOCATION INSTRUMENT 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.

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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 GUIDEWIREK901263NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

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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