CrossWise RF Transseptal System

Basic Information

• Brand Name: CrossWise RF Transseptal System
• Primary DI: 10851498007449
• Version / Model: CW-1085V
• Company Name: CIRCA Scientific, Inc.
• Labeler DUNS: 963223222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-28
• Public Version: 2
• Public Version Date: 2025-08-04
• Public Version Status: Update
• Public Device Record Key: 4fbfd863-a09e-4ee9-90d6-4cada1dd43f2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
DXF	Catheter, Septostomy	Cardiovascular	870.5175	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	10851498007449	GS1

Premarket Submissions

Submission Number	Supplement Number
K251007	000