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FDA 510(k)

ExpanSure Transseptal Dilation System

K-Number: K182064 · 2019-03-21

ApplicantBaylis Medical Company, Inc.
Decision Date2019-03-21
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ExpanSure Transseptal Dilation 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 2019-03-21 under 510(k) number K182064. 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 ExpanSure Transseptal Dilation System?

ExpanSure Transseptal Dilation System is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K182064.

When did ExpanSure Transseptal Dilation System receive FDA 510(k) clearance?

ExpanSure Transseptal Dilation System received FDA 510(k) clearance on 2019-03-21, under 510(k) number K182064.

Who is the listed applicant for ExpanSure Transseptal Dilation 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 ExpanSure Transseptal Dilation System?

The FDA product code for ExpanSure Transseptal Dilation System is DRE.

Other records listing Baylis Medical Company, Inc. as applicant

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.

K251325VersaCross Connect™ Transseptal DilatorK242076VersaCross™ RF WireK241720VersaCross Connect™ Transseptal DilatorK231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathK233647VersaCross Connect™ Transseptal DilatorK213898ProTrack Pigtail Wire

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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