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FDA 510(k)

HANAROSTENT Trachea/Bronchium (CCC)

K-Number: K201342 · 2020-12-31

ApplicantM.I.Tech Co., Ltd.
Decision Date2020-12-31
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Trachea/Bronchium (CCC) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-31 under 510(k) number K201342. 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 HANAROSTENT Trachea/Bronchium (CCC)?

HANAROSTENT Trachea/Bronchium (CCC) is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K201342.

When did HANAROSTENT Trachea/Bronchium (CCC) receive FDA 510(k) clearance?

HANAROSTENT Trachea/Bronchium (CCC) received FDA 510(k) clearance on 2020-12-31, under 510(k) number K201342.

Who is the listed applicant for HANAROSTENT Trachea/Bronchium (CCC)?

The FDA 510(k) record lists M.I.Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANAROSTENT Trachea/Bronchium (CCC)?

The FDA product code for HANAROSTENT Trachea/Bronchium (CCC) is JCT.

Other records listing M.I.Tech Co., Ltd. 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.

K253327HANAROSTENT Esophagus Upper (CCC)K213251HANAROSTENT Esophagus Asymmetric (CCC)K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)K190141HANAROSTENT LowAx Colon/Rectum (NNN)

View all 11 devices →

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.K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.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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