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FDA 510(k)

Ultraflex™ Tracheobronchial Stent System

K-Number: K230269 · 2023-07-14

Decision Date2023-07-14
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultraflex™ Tracheobronchial Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K230269. 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 Ultraflex™ Tracheobronchial Stent System?

Ultraflex™ Tracheobronchial Stent System is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Boston Scientific Corporation. The 510(k) number is K230269.

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

Ultraflex™ Tracheobronchial Stent System received FDA 510(k) clearance on 2023-07-14, under 510(k) number K230269.

Who is the listed applicant for Ultraflex™ Tracheobronchial Stent System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultraflex™ Tracheobronchial Stent System?

The FDA product code for Ultraflex™ Tracheobronchial Stent System 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.

Other records listing Boston Scientific Corporation 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.

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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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.