Rubicon 14, 18 And 35 Support Catheters

Catheter, Percutaneous

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rubicon 14, 18 And 35 Support Catheters.

Pre-market Notification Details

Device IDK171913
510k NumberK171913
Device Name:Rubicon 14, 18 And 35 Support Catheters
ClassificationCatheter, Percutaneous
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311 -1566
ContactKa Zoua Xiong
CorrespondentKa Zoua Xiong
Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311 -1566
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-26
Decision Date2017-07-25
Summary:summary

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