ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

Prosthesis, Esophageal

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultraflex Esophageal Ng Stent System.

Pre-market Notification Details

Device IDK130004
510k NumberK130004
Device Name:ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ClassificationProsthesis, Esophageal
Applicant Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
ContactJanis Taranto
CorrespondentJanis Taranto
Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-02
Decision Date2013-12-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.