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FDA 510(k)

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

K-Number: K021555 · 2003-01-15

ApplicantStereotaxis, Inc.
Decision Date2003-01-15
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2003-01-15 under 510(k) number K021555. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM?

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-15. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K021555.

When did STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM receive FDA 510(k) clearance?

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM received FDA 510(k) clearance on 2003-01-15, under 510(k) number K021555.

Who is the listed applicant for STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM?

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

What is the FDA product code for STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM?

The FDA product code for STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM is DXX.

Related Clinical Trials

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Other records listing Stereotaxis, 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.

K262744GenesisX RMNK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

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Related Devices (Code: DXX)

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.

K262744GenesisX RMNStereotaxis, Inc.K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.K221464CorPath GRX SystemCorindus, Inc.K202275CorPath GRX SystemCorindus, Inc.K180517CorPath GRX SystemCorindus, Inc.

Official Source

View on FDA Database →

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

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