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FDA 510(k)

CRONUS GUIDEWIRE, MODEL 001-001470-1

K-Number: K051373 · 2005-12-09

ApplicantStereotaxis, Inc.
Decision Date2005-12-09
Product CodeNDQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRONUS GUIDEWIRE, MODEL 001-001470-1 is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K051373. The device is classified under product code NDQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRONUS GUIDEWIRE, MODEL 001-001470-1?

CRONUS GUIDEWIRE, MODEL 001-001470-1 is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K051373.

When did CRONUS GUIDEWIRE, MODEL 001-001470-1 receive FDA 510(k) clearance?

CRONUS GUIDEWIRE, MODEL 001-001470-1 received FDA 510(k) clearance on 2005-12-09, under 510(k) number K051373.

Who is the listed applicant for CRONUS GUIDEWIRE, MODEL 001-001470-1?

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 CRONUS GUIDEWIRE, MODEL 001-001470-1?

The FDA product code for CRONUS GUIDEWIRE, MODEL 001-001470-1 is NDQ.

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Related Devices (Code: NDQ)

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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