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FDA 510(k)

ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM

K-Number: K060239 · 2006-03-22

ApplicantAlveolus, Inc.
Decision Date2006-03-22
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alveolus, Inc.. It received FDA 510(k) clearance on 2006-03-22 under 510(k) number K060239. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM?

ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-22. The listed applicant is Alveolus, Inc.. The 510(k) number is K060239.

When did ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM receive FDA 510(k) clearance?

ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM received FDA 510(k) clearance on 2006-03-22, under 510(k) number K060239.

Who is the listed applicant for ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM?

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

What is the FDA product code for ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM?

The FDA product code for ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM is ESW.

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Other records listing Alveolus, 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.

K083625AERO DV TRACHEOBRONCHIAL STENT SYSTEMK082284AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEMK080838ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEMK072720ALIMAXX-B UNCOVERED BILIARY STENT SYSTEMK071604ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEMK062511AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

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Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation

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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