Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

Catheter, Percutaneous

Biotronik, Inc

The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool.

Pre-market Notification Details

Device IDK192996
501k NumberK192996
Device Name:Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
ClassificationCatheter, Percutaneous
Applicant Biotronik, Inc 6024 Jean Road Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
Biotronik, Inc 6024 Jean Road Lake Oswego,  OR  97035
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-28
Decision Date2019-11-21

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