Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2019-05-20 under 510(k) 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. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K183655.

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

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

Who is the listed applicant for VersaCross Transseptal Sheath?

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 Transseptal Sheath?

The FDA product code for VersaCross Transseptal Sheath 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

View all 19 devices →

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.

↑