Epicardial Access System
K-Number: K213582 · 2022-06-30
ApplicantBaylis Medical Company, Inc.
Decision Date2022-06-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Epicardial Access System is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2022-06-30 under approval number K213582. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Epicardial Access System?
Epicardial Access System is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K213582.
When was Epicardial Access System approved by the FDA?
Epicardial Access System received FDA 510(k) clearance on 2022-06-30, under approval number K213582.
What company makes Epicardial Access System?
Epicardial Access System is manufactured by Baylis Medical Company, Inc..
What is the FDA product code for Epicardial Access System?
The FDA product code for Epicardial Access System is DYB.
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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.