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FDA 510(k)

ATRICURE CRYO MODULE

K-Number: K111042 · 2011-05-26

ApplicantAtriCure, Inc.
Decision Date2011-05-26
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRICURE CRYO MODULE is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2011-05-26 under 510(k) number K111042. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRICURE CRYO MODULE?

ATRICURE CRYO MODULE is a medical device that received FDA 510(k) clearance on 2011-05-26. The listed applicant is AtriCure, Inc.. The 510(k) number is K111042.

When did ATRICURE CRYO MODULE receive FDA 510(k) clearance?

ATRICURE CRYO MODULE received FDA 510(k) clearance on 2011-05-26, under 510(k) number K111042.

Who is the listed applicant for ATRICURE CRYO MODULE?

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

What is the FDA product code for ATRICURE CRYO MODULE?

The FDA product code for ATRICURE CRYO MODULE is GEH.

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Related Devices (Code: GEH)

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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