FDA 510(k)

GUIDANT MICROWAVE ABLATION SYSTEM

K-Number: K041340 · 2004-07-28

ApplicantGuidant Corporation, Cardiac Surgery

Decision Date2004-07-28

Product CodeNEY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GUIDANT MICROWAVE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation, Cardiac Surgery. It received FDA 510(k) clearance on 2004-07-28 under 510(k) number K041340. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDANT MICROWAVE ABLATION SYSTEM?

GUIDANT MICROWAVE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Guidant Corporation, Cardiac Surgery. The 510(k) number is K041340.

When did GUIDANT MICROWAVE ABLATION SYSTEM receive FDA 510(k) clearance?

GUIDANT MICROWAVE ABLATION SYSTEM received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041340.

Who is the listed applicant for GUIDANT MICROWAVE ABLATION SYSTEM?

The FDA 510(k) record lists Guidant Corporation, Cardiac Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUIDANT MICROWAVE ABLATION SYSTEM?

The FDA product code for GUIDANT MICROWAVE ABLATION SYSTEM is NEY.

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Other records listing Guidant Corporation, Cardiac Surgery as applicant

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Related Devices (Code: NEY)

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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.