VersaCross Connect LAAC Access Solution

Basic Information

• Brand Name: VersaCross Connect LAAC Access Solution
• Primary DI: 00685447012610
• Version / Model: VXAK0011
• Catalog Number: NA
• Company Name: Baylis Médicale Cie Inc
• Labeler DUNS: 249225954
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 5
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: b83d555c-9619-4a55-81c7-19e0134697bd
• Distribution End Date: 2023-11-01

Device Description

1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2
DXF	Catheter, Septostomy	Cardiovascular	870.5175	2
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47247	Cardiac transseptal access set	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00685447012610	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable)