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FDA 510(k)

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS

K-Number: K945494 · 1995-03-03

ApplicantBoston Scientific Scimed, Inc.
Decision Date1995-03-03
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 1995-03-03 under 510(k) number K945494. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS?

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-03-03. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K945494.

When did WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS receive FDA 510(k) clearance?

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS received FDA 510(k) clearance on 1995-03-03, under 510(k) number K945494.

Who is the listed applicant for WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS?

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

What is the FDA product code for WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS?

The FDA product code for WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS is JCT.

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Other records listing Boston Scientific Scimed, Inc. 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.

K041727MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIREK024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEMK021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETERK021901WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMK012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX

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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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