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FDA 510(k)

VersaCross Steerable Sheath, VersaCross Transseptal Dilator

K-Number: K190688 · 2019-04-17

ApplicantBaylis Medical Company, Inc.
Decision Date2019-04-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VersaCross Steerable Sheath, VersaCross Transseptal Dilator 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 2019-04-17 under 510(k) number K190688. 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 Steerable Sheath, VersaCross Transseptal Dilator?

VersaCross Steerable Sheath, VersaCross Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K190688.

When did VersaCross Steerable Sheath, VersaCross Transseptal Dilator receive FDA 510(k) clearance?

VersaCross Steerable Sheath, VersaCross Transseptal Dilator received FDA 510(k) clearance on 2019-04-17, under 510(k) number K190688.

Who is the listed applicant for VersaCross Steerable Sheath, VersaCross Transseptal Dilator?

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 VersaCross Steerable Sheath, VersaCross Transseptal Dilator?

The FDA product code for VersaCross Steerable Sheath, VersaCross Transseptal Dilator is DYB.

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: 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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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