CrossWise RF Transseptal System

GUDID 10851498007357

CIRCA SCIENTIFIC, LLC

Cardiac transseptal access set

• Primary Device ID: 10851498007357
• NIH Device Record Key: af56f6bb-c9d9-4c06-98c5-ac650d7e6b89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossWise RF Transseptal System
• Version Model Number: CW-1012W
• Company DUNS: 963223222
• Company Name: CIRCA SCIENTIFIC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851498007357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241414

FDA Product Code

• DXF: Catheter, Septostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

On-Brand Devices [CrossWise RF Transseptal System]

• 10851498007364: CW-1012C
• 10851498007357: CW-1012W
• 10851498007340: CW-1085A
• 10851498007333: CW-1085S