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FDA 510(k)

STEREOTAXIS CATHETER ADVANCER SYSTEM

K-Number: K021802 · 2003-04-08

ApplicantStereotaxis, Inc.
Decision Date2003-04-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEREOTAXIS CATHETER ADVANCER 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 2003-04-08 under 510(k) number K021802. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEREOTAXIS CATHETER ADVANCER SYSTEM?

STEREOTAXIS CATHETER ADVANCER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-08. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K021802.

When did STEREOTAXIS CATHETER ADVANCER SYSTEM receive FDA 510(k) clearance?

STEREOTAXIS CATHETER ADVANCER SYSTEM received FDA 510(k) clearance on 2003-04-08, under 510(k) number K021802.

Who is the listed applicant for STEREOTAXIS CATHETER ADVANCER 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 CATHETER ADVANCER SYSTEM?

The FDA product code for STEREOTAXIS CATHETER ADVANCER SYSTEM is DQY.

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Other records listing Stereotaxis, Inc. as applicant

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Related Devices (Code: DQY)

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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