FDA.reportPublic FDA data

510(k) K183655

Device
VersaCross Transseptal Sheath
Applicant
Baylis Medical Company Inc.
510(k) number
K183655
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
2019-05-20
Date received
2018-12-27
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Meghal Khakhar
Address
2645 Matheson Blvd. E. Mississauga CA L4W 4J1 L4W 4J1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260606Echo Large Bore Introducer SheathEcho Medical, LLC2026-04-29
K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
K254279Edwards eSheath+ introducer setEdwards Lifesciences2026-04-17
K260091Aventus Introducer SheathInquis Medical2026-04-13
K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.2026-04-10
K260942AuST Steerable SheathCenterPoint Systems, LLC2026-04-07
K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.2026-04-06
K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.2026-03-26
K260163AuST CSP IntroducerCenterPoint Systems, LLC2026-02-19
K254236Peel-Away Introducer SheathVascuTech Medical, LLC2026-02-09
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC2026-01-22
K252508Intri26 Introducer SheathInari Medical, Inc.2025-12-17
K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.2025-12-15
K252309PerQseal IntroducersVivasure Medical Limited2025-10-23
K251838Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2025-10-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases