Carto 3 Navigation System (Model: FG-5400-00), Carto 3 External Reference Patches (Model: D-1283-01)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072202 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Carto 3 Navigation System (Model: FG-5400-00) is an electroanatomical mapping system designed for three-dimensional visualization of cardiac structures during electrophysiological procedures. It integrates real-time mapping data to guide catheter ablation, electrophysiology studies, and other interventional cardiac interventions, enhancing procedural precision and safety.
This system is supplied as a reusable medical device, paired with single-use external reference patches (Model: D-1283-01) for accurate spatial mapping. It operates in clinical electrophysiology labs and is regulated under FDA 510(k) clearance (K072202) and EU MDR compliance. The device requires proper calibration, sterile handling of consumables, and adherence to manufacturer guidelines for optimal performance and patient safety.
Frequently asked questions
What types of cardiac procedures is the Carto 3 Navigation System primarily used for, and how does it improve precision during these interventions?
The Carto 3 Navigation System is designed for electrophysiological procedures, including catheter ablation and electrophysiology studies. It enhances procedural precision by providing real-time, three-dimensional visualization of cardiac structures, allowing clinicians to map electrical activity and guide catheters with greater accuracy. This reduces the risk of complications and improves outcomes by ensuring targeted interventions.
Are the external reference patches (Model: D-1283-01) reusable or single-use, and why does this matter for clinical workflow?
The Carto 3 External Reference Patches (Model: D-1283-01) are explicitly labeled as single-use. This matters for clinical workflow because single-use consumables minimize the risk of cross-contamination between patients, ensuring sterility and patient safety. Reusing them could compromise accuracy and introduce infection risks, so adhering to single-use guidelines is critical.
How is the Carto 3 Navigation System regulated, and what does this mean for healthcare providers in terms of compliance?
The Carto 3 Navigation System is regulated under FDA 510(k) clearance (K072202) and EU MDR compliance. For healthcare providers, this means the device meets U.S. and European safety and performance standards, but they must still follow manufacturer guidelines for calibration, sterile handling of consumables, and proper use to maintain compliance and ensure optimal performance during procedures.
What clinical setting is the Carto 3 Navigation System intended for, and what role do the external reference patches play in its functionality?
The Carto 3 Navigation System is intended for use in clinical electrophysiology labs, where precise mapping of cardiac anatomy is essential. The external reference patches (Model: D-1283-01) are critical for accurate spatial mapping—they provide reference points for the system to create a detailed 3D model of the heart, ensuring the catheter’s position is tracked reliably during procedures like ablation.
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: Carto – geprüfte Qualität für Schule, Ausbildung und Präsentation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K072202 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (2)
- FDA 510(k) K072202 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026