FDA.report

VersaCross Steerable Access Solution

Primary DI
00685447010265
Brand
VersaCross Steerable Access Solution
Company
Baylis Médicale Cie Inc
Model
VSTK0035
Device description
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)); 1 x Dispersive Electrode
Published
2022-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYBIntroducer, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00685447010265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447010265006854470102656854470102650685447010265

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags

DUNS number
249225954
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00685447019466VersaCross Connect™ LAAC Access SolutionVXAK0101VXAK01012025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionVXAK0103VXAK01032025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionVXAK0105VXAK01052025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionVXAK0107VXAK01072025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionVXAK0109VXAK01092025-02-25
00685447019558VersaCross™ Large Access SolutionVLAK0102VLAK01022025-02-25
00685447019565VersaCross™ Large Access SolutionVLAK0109VLAK01092025-02-25
00685447019572VersaCross™ Large Access SolutionVLAK0110VLAK01102025-02-25
00685447019589VersaCross™ Large Access SolutionVLAK0113VLAK01132025-02-25
00685447019596VersaCross™ Large Access SolutionVLAK0114VLAK01142025-02-25
00685447019602VersaCross™ Steerable Access SolutionVSTK0102VSTK01022025-02-25
00685447019619VersaCross™ Steerable Access SolutionVSTK0103VSTK01032025-02-25
00685447019626VersaCross™ Steerable Access SolutionVSTK0104VSTK01042025-02-25
00685447019633VersaCross™ Steerable Access SolutionVSTK0106VSTK01062025-02-25
00685447019640VersaCross™ Steerable Access SolutionVSTK0114VSTK01142025-02-25
00685447019657VersaCross™ Steerable Access SolutionVSTK0115VSTK01152025-02-25
00685447019664VersaCross™ Steerable Access SolutionVSTK0116VSTK01162025-02-25
00685447019671VersaCross™ Steerable Access SolutionVSTK0117VSTK01172025-02-25
00685447019688VersaCross™ Steerable Access SolutionVSTK0118VSTK01182025-02-25
00685447019695VersaCross™ Steerable Access SolutionVSTK0120VSTK01202025-02-25

Other Devices Sharing Product Codes

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20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.DYB2026-03-11
20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
20884450113992Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
20884450115804Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.DYB2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
20801902225362ARROWTELEFLEX INCORPORATEDDYB2026-02-17
20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13
20801902225171ARROWTELEFLEX INCORPORATEDDYB2026-02-13
00884450465981HeartSpan®Merit Medical Systems, Inc.DYB2026-02-07