Selectra Catheters And Selectra Accessory Kit

Catheter, Percutaneous

BIOTRONIK, INC.

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

Pre-market Notification Details

Device IDK151409
510k NumberK151409
Device Name:Selectra Catheters And Selectra Accessory Kit
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 - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-26
Decision Date2015-08-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.