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FDA 510(k)

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM

K-Number: K030107 · 2003-03-21

ApplicantBoston Scientific Corp
Decision Date2003-03-21
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030107. 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 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM?

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Boston Scientific Corp. The 510(k) number is K030107.

When did 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM receive FDA 510(k) clearance?

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030107.

Who is the listed applicant for 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM?

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

What is the FDA product code for 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM?

The FDA product code for 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM 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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