CrossWise Multi-Use RF Adapter Cable

GUDID 10851498007371

CIRCA SCIENTIFIC, LLC

Cardiac transseptal access set

• Primary Device ID: 10851498007371
• NIH Device Record Key: 4ddd38e8-5f9e-42f4-9f9b-62a3d99f3d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossWise Multi-Use RF Adapter Cable
• Version Model Number: CW-1001
• 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: false
• 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	10851498007371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243193

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

Devices Manufactured by CIRCA SCIENTIFIC, LLC

• 10851498007333 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007340 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007357 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007364 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007371 - CrossWise Multi-Use RF Adapter Cable: 2024-12-10
• 10851498007371 - CrossWise Multi-Use RF Adapter Cable: 2024-12-10
• 00851498007381 - CIRCA Temperature Monitoring System: 2024-11-08
• 10851498007197 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007203 - CardioCurve Steerable Sheath: 2024-08-09