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FDA 510(k)

VersaCross Connect™ Transseptal Dilator

K-Number: K251325 · 2025-05-29

ApplicantBaylis Medical Company, Inc.
Decision Date2025-05-29
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VersaCross Connect™ Transseptal Dilator is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2025-05-29 under approval number K251325. 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 VersaCross Connect™ Transseptal Dilator?

VersaCross Connect™ Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K251325.

When was VersaCross Connect™ Transseptal Dilator approved by the FDA?

VersaCross Connect™ Transseptal Dilator received FDA 510(k) clearance on 2025-05-29, under approval number K251325.

What company makes VersaCross Connect™ Transseptal Dilator?

VersaCross Connect™ Transseptal Dilator is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for VersaCross Connect™ Transseptal Dilator?

The FDA product code for VersaCross Connect™ Transseptal Dilator 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.

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