WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING

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 Wallstent Tracheobronchial Endoprosthesis And Wallstent Tracheobronchial Endoprosthesis With Permalume Covering.

Pre-market Notification Details

Device IDK980163
510k NumberK980163
Device Name:WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
ClassificationProsthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
ContactRonald W Bennett
CorrespondentRonald W 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 Received1998-01-16
Decision Date1998-03-13
Summary:summary

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