VersaCross Steerable Access Solution NA

GUDID 00685447006633

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

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447006633
• NIH Device Record Key: aee499e6-7c3c-4fee-bca8-eb56db0ce26d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Steerable Access Solution
• Version Model Number: VSTK-35J-230-85-BD-71M-D1
• Catalog Number: NA
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
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• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447006633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150709

FDA Product Code

• DXF: Catheter, Septostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [VersaCross Steerable Access Solution]

• 00685447006763: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006756: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006749: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006725: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006701: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006695: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006688: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006664: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006640: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006633: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006626: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006602: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006589: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006572: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006565: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006541: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006770: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006732: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006718: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006671: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006657: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006619: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006596: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006558: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007210: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007203: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007197: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007180: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007173: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007166: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007159: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007142: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007135: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007128: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007111: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007104: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007098: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007081: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007074: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007067: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007050: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007043: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007036: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007029: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007012: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447007005: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006992: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447006985: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447010449: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross
• 00685447010432: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross