ExpanSure Large Access Transseptal Dilator

Dilator, Vessel, For Percutaneous Catheterization

Baylis Medical Company Inc.

The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Expansure Large Access Transseptal Dilator.

Pre-market Notification Details

Device IDK201288
510k NumberK201288
Device Name:ExpanSure Large Access Transseptal Dilator
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant Baylis Medical Company Inc. 2580 Matheson Blvd. East Mississauga,  CA L4w 4j1
ContactMay Tsai
CorrespondentMay Tsai
Baylis Medical Company Inc. 2580 Matheson Blvd. East Mississauga,  CA L4w 4j1
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-14
Decision Date2020-06-12

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