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FDA 510(k)

VersaCross Connect Transseptal Dilator

K-Number: K220414 · 2022-05-09

ApplicantBaylis Medical Company, Inc.
Decision Date2022-05-09
Product CodeDYB
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 2022-05-09 under approval number K220414. 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 Connect Transseptal Dilator?

VersaCross Connect Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2022-05-09. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K220414.

When was VersaCross Connect Transseptal Dilator approved by the FDA?

VersaCross Connect Transseptal Dilator received FDA 510(k) clearance on 2022-05-09, under approval number K220414.

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 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.

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