Oscar Peripheral Multifunctional Catheter System

Catheter, Angioplasty, Peripheral, Transluminal

BIOTRONIK, Inc.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Oscar Peripheral Multifunctional Catheter System.

Pre-market Notification Details

Device IDK214038
510k NumberK214038
Device Name:Oscar Peripheral Multifunctional Catheter System
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant BIOTRONIK, Inc. 6024 Jean Road Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego,  OR  97035
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-23
Decision Date2022-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640130455801 K214038 000
07640130455689 K214038 000
07640130455672 K214038 000
07640130455665 K214038 000
07640130455658 K214038 000
07640130455641 K214038 000
07640130455634 K214038 000
07640130455627 K214038 000
07640130455610 K214038 000
07640130455603 K214038 000
07640130455696 K214038 000
07640130455702 K214038 000
07640130455795 K214038 000
07640130455788 K214038 000
07640130455771 K214038 000
07640130455764 K214038 000
07640130455757 K214038 000
07640130455740 K214038 000
07640130455733 K214038 000
07640130455726 K214038 000
07640130455719 K214038 000
07640130455597 K214038 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.