Breezeway II

Introducer, Catheter

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Breezeway Ii.

Pre-market Notification Details

Device IDK210627
510k NumberK210627
Device Name:Breezeway II
ClassificationIntroducer, Catheter
Applicant Oscor Inc. 3816 DeSoto Boulevard Palm Harbor,  FL  34683
ContactDoug Myers
CorrespondentDoug Myers
Oscor Inc. 3816 DeSoto Boulevard Palm Harbor,  FL  34683
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-02
Decision Date2021-06-03

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