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FDA 510(k)

AEROmini Tracheobronchial Stent System

K-Number: K181200 · 2018-09-21

ApplicantMerit Medical Systems, Inc.
Decision Date2018-09-21
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AEROmini Tracheobronchial Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181200. 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 AEROmini Tracheobronchial Stent System?

AEROmini Tracheobronchial Stent System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K181200.

When did AEROmini Tracheobronchial Stent System receive FDA 510(k) clearance?

AEROmini Tracheobronchial Stent System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181200.

Who is the listed applicant for AEROmini Tracheobronchial Stent System?

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

What is the FDA product code for AEROmini Tracheobronchial Stent System?

The FDA product code for AEROmini Tracheobronchial Stent System is JCT.

Related Clinical Trials

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Other records listing Merit Medical Systems, Inc. as applicant

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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.K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston 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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