FDA.reportPublic FDA data

VersaCross Access Solution

Primary DI
00685447011781
Brand
VersaCross Access Solution
Company
Baylis Médicale Cie Inc
Model
VXSK0027
Catalog number
NA
Device description
1 x VersaCross Transseptal Sheath (including 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Published
2022-07-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXFCatheter, Septostomy
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447011781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447011781006854470117816854470117810685447011781

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447010487VersaCross Connect Transseptal Dilator VXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447005247VersaCross Large Access Transseptal DilatorVLA125-35-67-D0NA2021-06-10
00685447005254VersaCross Large Access Transseptal DilatorVLA125-35-67-D1NA2021-06-10
00685447005261VersaCross Large Access Transseptal DilatorVLA125-35-85-D0NA2021-06-10
00685447005278VersaCross Large Access Transseptal DilatorVLA125-35-85-D1NA2021-06-10
00685447005735VersaCross Steerable SheathVST85-35-BD-71L-D0NA2021-04-08
00685447005759VersaCross Steerable SheathVST85-35-BD-71M-D0NA2021-04-08
00685447005766VersaCross Steerable SheathVST85-35-BD-71M-D1NA2021-04-08
00685447005780VersaCross Steerable SheathVST85-35-BD-71S-D1NA2021-04-08
00685447003380VersaCross Transseptal SheathVXS85-35-63-45-D02019-06-26
00685447003397VersaCross Transseptal SheathVXS85-35-63-55-D02019-06-26
00685447003281VersaCross RF WireVXW-35-180-J2019-05-01
00685447003298VersaCross RF WireVXW-35-180-P2019-05-01
00685447003304VersaCross RF WireVXW-35-230-J2019-05-01
00685447003311VersaCross RF WireVXW-35-230-P2019-05-01
00685447000938RFP-100A Connector CableRFX-BAY-OTW-12-SU2016-08-15
00685447001027Adult Dispersive ElectrodeRFA-GP-BAY2017-02-03
00685447011774VersaCross Access SolutionVXSK0026NA2022-07-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355120ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355130ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355160ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355170ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355180ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355190ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965481000ENVINAVILYST MEDICAL, INC.DYB2017-08-07