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FDA 510(k)

ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM

K-Number: K033990 · 2004-05-12

ApplicantAlveolus, Inc.
Decision Date2004-05-12
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL 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 2004-05-12 under 510(k) number K033990. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM?

ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-12. The listed applicant is Alveolus, Inc.. The 510(k) number is K033990.

When did ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM receive FDA 510(k) clearance?

ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM received FDA 510(k) clearance on 2004-05-12, under 510(k) number K033990.

Who is the listed applicant for ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL 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 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM?

The FDA product code for ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM is JCT.

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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: JCT)

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.

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific CorporationK220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.

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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