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FDA 510(k)

WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

K-Number: K993232 · 1999-12-30

ApplicantBoston Scientific Scimed, Inc.
Decision Date1999-12-30
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

WALLSTENT BILIARY ENDOPROSTHESIS AND 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 1999-12-30 under 510(k) number K993232. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM?

WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-30. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K993232.

When did WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM receive FDA 510(k) clearance?

WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM received FDA 510(k) clearance on 1999-12-30, under 510(k) number K993232.

Who is the listed applicant for WALLSTENT BILIARY ENDOPROSTHESIS AND 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 WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM?

The FDA product code for WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM is FGE.

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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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