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FDA 510(k)

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

K-Number: K021901 · 2002-07-09

ApplicantBoston Scientific Scimed, Inc.
Decision Date2002-07-09
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM 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 2002-07-09 under 510(k) number K021901. 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 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM?

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-09. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K021901.

When did WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM receive FDA 510(k) clearance?

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM received FDA 510(k) clearance on 2002-07-09, under 510(k) number K021901.

Who is the listed applicant for WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM?

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 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM?

The FDA product code for WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM is JCT.

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Related Devices (Code: JCT)

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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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