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FDA 510(k)

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS

K-Number: K080637 · 2008-08-12

ApplicantStereotaxis, Inc.
Decision Date2008-08-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2008-08-12 under 510(k) number K080637. 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 POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS?

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS is a medical device that received FDA 510(k) clearance on 2008-08-12. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K080637.

When did POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS receive FDA 510(k) clearance?

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS received FDA 510(k) clearance on 2008-08-12, under 510(k) number K080637.

Who is the listed applicant for POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS?

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 POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS?

The FDA product code for POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS is DQX.

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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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