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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 a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-09-21 under approval 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. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K181200.

When was AEROmini Tracheobronchial Stent System approved by the FDA?

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

What company makes AEROmini Tracheobronchial Stent System?

AEROmini Tracheobronchial Stent System is manufactured by Merit Medical Systems, Inc..

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

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05864560 Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up ACTIVE_NOT_RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED

Related PubMed Literature

PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

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Related Devices (Code: JCT)

K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd. K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K230269Ultraflex™ Tracheobronchial 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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