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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 the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) 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. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K191546.

When did Epicardial Access System receive FDA 510(k) clearance?

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

Who is the listed applicant for Epicardial Access System?

The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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