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FDA 510(k)

FLUENCY TRACHEOBRONCHIAL STENT GRAFT

K-Number: K031041 · 2003-06-19

ApplicantBard Peripheral Vascular
Decision Date2003-06-19
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUENCY TRACHEOBRONCHIAL STENT GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K031041. 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 FLUENCY TRACHEOBRONCHIAL STENT GRAFT?

FLUENCY TRACHEOBRONCHIAL STENT GRAFT is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is Bard Peripheral Vascular. The 510(k) number is K031041.

When did FLUENCY TRACHEOBRONCHIAL STENT GRAFT receive FDA 510(k) clearance?

FLUENCY TRACHEOBRONCHIAL STENT GRAFT received FDA 510(k) clearance on 2003-06-19, under 510(k) number K031041.

Who is the listed applicant for FLUENCY TRACHEOBRONCHIAL STENT GRAFT?

The FDA 510(k) record lists Bard Peripheral Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUENCY TRACHEOBRONCHIAL STENT GRAFT?

The FDA product code for FLUENCY TRACHEOBRONCHIAL STENT GRAFT is JCT.

Related Clinical Trials

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.

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Other records listing Bard Peripheral Vascular 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.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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