FDA 510(k)

EnsoETM

K-Number: K172029 · 2018-01-05

Decision Date2018-01-05

Product CodePLA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EnsoETM is the device name listed in this FDA 510(k) record. The listed applicant is Attune Medical. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K172029. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnsoETM?

EnsoETM is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Attune Medical. The 510(k) number is K172029.

When did EnsoETM receive FDA 510(k) clearance?

EnsoETM received FDA 510(k) clearance on 2018-01-05, under 510(k) number K172029.

Who is the listed applicant for EnsoETM?

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

What is the FDA product code for EnsoETM?

The FDA product code for EnsoETM is PLA.

Other records listing Attune Medical 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.

K172493EnsoETM

Related Devices (Code: PLA)

K250632Arctx Cool Catheter SetArctx Medical K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K172493EnsoETMAttune Medical K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.