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FDA 510(k)

Epicardial Access System

K-Number: K191546 · 2019-08-02

ApplicantBaylis Medical Company, Inc.
Decision Date2019-08-02
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 2019-08-02 under approval number K191546. 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 2019-08-02. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K191546.

When was Epicardial Access System approved by the FDA?

Epicardial Access System received FDA 510(k) clearance on 2019-08-02, under approval number K191546.

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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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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.

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