Emerge PTCA Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Emerge Ptca Dilatation Catheter.

Pre-market Notification Details

Device IDK163174
510k NumberK163174
Device Name:Emerge PTCA Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
ContactJane Horan
CorrespondentJane Horan
Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-14
Decision Date2016-12-14
Summary:summary

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