CARTO 3 EP Navigation System, V1.0 And Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090017 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 EP Navigation System, V1.0 And Accessories is a cardiovascular device used for electrophysiology procedures. It provides navigation and mapping capabilities during cardiac interventions.
The system is supplied by Biosense Webster Inc. and is authorized under FDA 510K clearance with product code DQK. It is intended for use in cardiovascular procedures and is not specified as single-use or reusable in the provided data.
Frequently asked questions
What is the CARTO 3 EP Navigation System used for?
The CARTO 3 EP Navigation System is a cardiovascular device used for electrophysiology procedures, providing navigation and mapping capabilities during cardiac interventions.
Is the CARTO 3 EP Navigation System single-use or reusable?
The provided data does not specify whether the CARTO 3 EP Navigation System is single-use or reusable. The device is intended for use in cardiovascular procedures.
What is the regulatory status of the CARTO 3 EP Navigation System?
The CARTO 3 EP Navigation System is authorized under FDA 510K clearance with product code DQK. It was received by the FDA in 2009 and received a decision date in October 2009.
Who manufactures the CARTO 3 EP Navigation System?
The CARTO 3 EP Navigation System is manufactured by Biosense Webster Inc., located at 3333 Diamond Canyon Rd., Diamond Bar, CA 91765.
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, ANALOGE VISUALISIERUNGSSYSTEME - Carto
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090017 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K090017 24 fields · synced Sep 23, 2026