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FDA 510(k)

VersaCross Transseptal Sheath

K-Number: K183655 · 2019-05-20

ApplicantBaylis Medical Company, Inc.
Decision Date2019-05-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VersaCross Transseptal Sheath is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-05-20 under approval number K183655. 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 VersaCross Transseptal Sheath?

VersaCross Transseptal Sheath is a medical device that received FDA 510(k) clearance on 2019-05-20. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K183655.

When was VersaCross Transseptal Sheath approved by the FDA?

VersaCross Transseptal Sheath received FDA 510(k) clearance on 2019-05-20, under approval number K183655.

What company makes VersaCross Transseptal Sheath?

VersaCross Transseptal Sheath is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for VersaCross Transseptal Sheath?

The FDA product code for VersaCross Transseptal Sheath is DYB.

Other Devices by Baylis Medical Company, Inc.

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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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