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FDA 510(k)

Tracheal Stent System (Y-Shaped)

K-Number: K212403 · 2021-10-30

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-10-30
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tracheal Stent System (Y-Shaped) is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-30 under approval number K212403. 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 Tracheal Stent System (Y-Shaped)?

Tracheal Stent System (Y-Shaped) is a medical device that received FDA 510(k) clearance on 2021-10-30. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K212403.

When was Tracheal Stent System (Y-Shaped) approved by the FDA?

Tracheal Stent System (Y-Shaped) received FDA 510(k) clearance on 2021-10-30, under approval number K212403.

What company makes Tracheal Stent System (Y-Shaped)?

Tracheal Stent System (Y-Shaped) is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Tracheal Stent System (Y-Shaped)?

The FDA product code for Tracheal Stent System (Y-Shaped) 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: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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Related Devices (Code: JCT)

K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc. K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech 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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