WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

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.

Pre-market Notification Details

Device IDK964121
510k NumberK964121
Device Name:WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
ClassificationProsthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
ContactCathy Yohnk
CorrespondentCathy Yohnk
BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
Product CodeJCT  
CFR Regulation Number878.3720 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-15
Decision Date1996-12-04
Summary:summary

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