PeriCross Epicardial Access Kit

GUDID 10851498007395

CIRCA SCIENTIFIC, LLC

Epicardial catheter introduction set

• Primary Device ID: 10851498007395
• NIH Device Record Key: afa229f9-9bcd-42e2-b5f8-94cad4f7bcab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriCross Epicardial Access Kit
• Version Model Number: PC-1013
• Company DUNS: 963223222
• Company Name: CIRCA SCIENTIFIC, LLC
• 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: 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	10851498007395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243954

FDA Product Code

• DYB: Introducer, Catheter

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: 2025-07-31
• Device Publish Date: 2025-07-23

Devices Manufactured by CIRCA SCIENTIFIC, LLC

• 10851498007395 - PeriCross Epicardial Access Kit: 2025-07-31
• 10851498007395 - PeriCross Epicardial Access Kit: 2025-07-31
• 10851498007432 - CrossWise RF Transseptal System: 2025-06-05
• 10851498007449 - CrossWise RF Transseptal System: 2025-06-05
• 10851498007456 - CrossWise RF Transseptal System: 2025-06-05
• 00851498007404 - CIRCA Temperature Monitoring System: 2025-02-24
• 10851498007333 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007340 - CrossWise RF Transseptal System: 2024-12-10
• 10851498007357 - CrossWise RF Transseptal System: 2024-12-10