WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

Prosthesis, Tracheal, Expandable

BOSTON SCIENTIFIC SCIMED, INC.

The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallgraft Tracheobronchial Endoprosthesis And Unistep Delivery System.

Pre-market Notification Details

Device IDK000001
510k NumberK000001
Device Name:WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
ClassificationProsthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
ContactRon Bennett
CorrespondentRon Bennett
BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
Product CodeJCT  
CFR Regulation Number878.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-03
Decision Date2000-06-05

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