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FDA 510(k)

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION

K-Number: K934116 · 1994-06-02

ApplicantBoston Scientific Scimed, Inc.
Decision Date1994-06-02
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION 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 1994-06-02 under 510(k) number K934116. 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 TRACHEOBRONCHIAL PROSTHESIS MODIFICATION?

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K934116.

When did WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION receive FDA 510(k) clearance?

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION received FDA 510(k) clearance on 1994-06-02, under 510(k) number K934116.

Who is the listed applicant for WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION?

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 TRACHEOBRONCHIAL PROSTHESIS MODIFICATION?

The FDA product code for WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION is JCT.

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Other records listing Boston Scientific Scimed, Inc. 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.

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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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