FDA.reportPublic FDA data

VersaCross Access Solution

Primary DI
00685447005148
Brand
VersaCross Access Solution
Company
Baylis Médicale Cie Inc
Model
VXSK-35J-230-81-55-D0
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)); 1 x Dispersive Electrode
Published
2021-07-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150709000ProTrack RF Anchor WireBaylis Medical Company, Inc.2015-06-17DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447005148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447005148006854470051486854470051480685447005148

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
00685447006978Epicardial Steerable Guiding SheathESK85-35-BD-45SNA2022-07-21
00685447007623Epicardial Introducer and StyletEPI85-35-15-BSNA2022-07-21
00685447010487VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447010159VersaCross Steerable SheathVST00072022-05-09
00685447010166VersaCross Steerable SheathVST00092022-05-09
00685447010173VersaCross Steerable SheathVST00112022-05-09
00685447010180VersaCross Steerable SheathVST00132022-05-09
00685447010197VersaCross Steerable SheathVST00152022-05-09
00685447010203VersaCross Steerable SheathVST00172022-05-09
00685447010456SureFlex Steerable Guiding SheathTSK00072022-05-09
00685447010463SureFlex Steerable Guiding SheathTSK00092022-05-09
00685447010470SureFlex Steerable Guiding SheathTSK00112022-05-09
00685447005285TorFlex Transseptal Guiding SheathTF8-32-63-372021-11-01
00685447005292TorFlex Transseptal Guiding SheathTF8-32-63-452021-11-01
00685447005308TorFlex Transseptal Guiding SheathTF8-32-63-552021-11-01
00685447005315TorFlex Transseptal Guiding SheathTF8-32-63-902021-11-01
00685447005322TorFlex Transseptal Guiding SheathTF8-32-63-1352021-11-01
00685447005339TorFlex Transseptal Guiding SheathTF8-32-81-372021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DXF2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30