SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

Catheter, Percutaneous

BOSTON SCIENTIFIC SCIMED, INC.

The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Schneider Guider Softip Guiding Catheters.

Pre-market Notification Details

Device IDK981413
510k NumberK981413
Device Name:SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
ClassificationCatheter, Percutaneous
Applicant BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
ContactMaria Brittle
CorrespondentMaria Brittle
BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis,  MN  55442
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-20
Decision Date1998-05-13
Summary:summary

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