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FDA 510(k)

ATRILAZE SURGICAL ABLATION SYSTEM

K-Number: K060680 · 2006-04-11

ApplicantMedical Cv, Inc.
Decision Date2006-04-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRILAZE SURGICAL ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Cv, Inc.. It received FDA 510(k) clearance on 2006-04-11 under 510(k) number K060680. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRILAZE SURGICAL ABLATION SYSTEM?

ATRILAZE SURGICAL ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-11. The listed applicant is Medical Cv, Inc.. The 510(k) number is K060680.

When did ATRILAZE SURGICAL ABLATION SYSTEM receive FDA 510(k) clearance?

ATRILAZE SURGICAL ABLATION SYSTEM received FDA 510(k) clearance on 2006-04-11, under 510(k) number K060680.

Who is the listed applicant for ATRILAZE SURGICAL ABLATION SYSTEM?

The FDA 510(k) record lists Medical Cv, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATRILAZE SURGICAL ABLATION SYSTEM?

The FDA product code for ATRILAZE SURGICAL ABLATION SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Medical Cv, Inc. as applicant

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.

K081457ATRILAZE LASER ABLATION SYSTEMK061489ATRILAZE MI SURGICAL ABLATION SYSTEMK052495ATRILAZE MALLEABLE ABLATION PROBEK040744ATRILAZE SOFT TISSUE ABLATION SYSTEMK033685NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

Related Devices (Code: GEX)

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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