ExpanSure Transseptal Dilation System
K-Number: K182064 · 2019-03-21
ApplicantBaylis Medical Company, Inc.
Decision Date2019-03-21
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ExpanSure Transseptal Dilation System is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-03-21 under approval number K182064. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ExpanSure Transseptal Dilation System?
ExpanSure Transseptal Dilation System is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K182064.
When was ExpanSure Transseptal Dilation System approved by the FDA?
ExpanSure Transseptal Dilation System received FDA 510(k) clearance on 2019-03-21, under approval number K182064.
What company makes ExpanSure Transseptal Dilation System?
ExpanSure Transseptal Dilation System is manufactured by Baylis Medical Company, Inc..
What is the FDA product code for ExpanSure Transseptal Dilation System?
The FDA product code for ExpanSure Transseptal Dilation System is DRE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.