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FDA 510(k)

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

K-Number: K051374 · 2005-06-23

ApplicantStereotaxis, Inc.
Decision Date2005-06-23
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODRIVE CATHETER ADVANCEMENT 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 2005-06-23 under 510(k) number K051374. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIODRIVE CATHETER ADVANCEMENT SYSTEM?

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-23. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K051374.

When did CARDIODRIVE CATHETER ADVANCEMENT SYSTEM receive FDA 510(k) clearance?

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM received FDA 510(k) clearance on 2005-06-23, under 510(k) number K051374.

Who is the listed applicant for CARDIODRIVE CATHETER ADVANCEMENT 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 CARDIODRIVE CATHETER ADVANCEMENT SYSTEM?

The FDA product code for CARDIODRIVE CATHETER ADVANCEMENT SYSTEM is DQX.

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Other records listing Stereotaxis, Inc. as applicant

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Related Devices (Code: DQX)

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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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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