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CrossWise RF Transseptal Access System - CW-1012W

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251007

by CIRCA Scientific, Inc.

Identifiers

510(k) Number
K251007 FDA 510(k)
FDA Product Code
DXF FDA 510(k)
Models / Variants
Models: CW-1085S FDA 510(k)
CW-1085A FDA 510(k)
CW-1012W FDA 510(k)
CW-1012C FDA 510(k)
CW-1085C FDA 510(k)
CW-1085V FDA 510(k)
CW-1013F FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5175 FDA 510(k)
Regulation Number
870.5175 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CrossWise RF Transseptal Access System is a septostomy catheter designed to create transcatheter access between the right and left atria via the fossa ovalis using monopolar radiofrequency energy. This device facilitates transseptal punctures in cardiac procedures, enabling interventions such as ablation or device implantation in the left atrium.

The system is supplied as a sterile, single-use device and is intended for use in electrophysiology laboratories. Models include varying configurations for procedural adaptability, with regulatory clearance under FDA 510(k) classification (K251007) as a Class II device under regulation 870.5175. Compliance with MRI safety standards is not specified, and storage follows standard sterile medical device protocols.

Frequently asked questions

What types of cardiac procedures can the CrossWise RF Transseptal Access System be used for, and why is transseptal access important in these cases?

The CrossWise RF Transseptal Access System is designed to create transcatheter access between the right and left atria via the fossa ovalis, enabling procedures like atrial ablation or left atrial device implantation. Transseptal access is critical in these cases because it allows clinicians to reach the left atrium—a chamber often inaccessible through standard venous routes—without open-heart surgery, facilitating treatments for arrhythmias or structural heart conditions.

Are the different model numbers (e.g., CW-1085S, CW-1012W) interchangeable, or do they serve distinct procedural purposes?

The model numbers (CW-1085S, CW-1085A, CW-1012W, etc.) indicate varying configurations tailored for procedural adaptability, but they are not universally interchangeable. Each model is likely designed to accommodate specific patient anatomies, catheter sizes, or procedural requirements. Clinicians should consult the manufacturer’s instructions for use to determine compatibility based on the intended application, such as sheath size or electrode design.

How should the CrossWise RF Transseptal Access System be stored, and what precautions should be taken to maintain sterility?

The system is supplied as a sterile, single-use device, so storage must follow standard sterile medical device protocols. It should be kept in its original packaging, protected from contamination, and stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediate use to preserve sterility, as re-sterilization is not recommended for single-use devices.

Is the CrossWise RF Transseptal Access System compatible with MRI procedures, and if not, what alternatives should be considered?

The device specifications do not explicitly state compliance with MRI safety standards, meaning its compatibility with MRI procedures is not confirmed. If MRI imaging is required post-procedure, alternative imaging modalities (e.g., CT or ultrasound) should be considered, or the device should be removed before MRI. Always verify with the manufacturer or radiology team for specific protocols.

Why was the CrossWise RF Transseptal Access System cleared under a ‘Special’ 510(k) classification, and what does this imply for clinicians?

The ‘Special’ 510(k) classification indicates that the device’s design or intended use may involve novel features or higher-risk considerations compared to traditional transseptal catheters, requiring additional scrutiny by the FDA. For clinicians, this implies that the device has undergone rigorous review for safety and effectiveness, particularly in its use of monopolar radiofrequency energy for septostomy. It also suggests that training or specialized expertise may be necessary for proper use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW ..., PDF CrossWiseTM RF Transseptal Access System, CrossWise RF Transseptal Access System (Models… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CIRCA Scientific, Inc.

Sources (1)

  • FDA 510(k) K251007 24 fields · synced Sep 19, 2026