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Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113213

by Biosense Webster Inc

Identifiers

510(k) Number
K113213 FDA 510(k)
FDA Product Code
DRF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1220 FDA 510(k)
Regulation Number
870.1220 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a catheter, electrode recording, or probe, electrode recording, as defined by its device type and nomenclature. It is a deflectable circular mapping catheter with a 4.5 F spine on its distal tip and platinum electrodes used for stimulation and recording of electrograms in the atrial regions of the heart.

The LASSO 2515 NAV ECO VARIABLE CATHETER is supplied in fixed and variable configurations with 10 or 20 electrodes, available in diameters of 15 mm, 20 mm, or 25 mm and a French size of 7F, with a length of 115 cm. It provides location information when used with a compatible CARTO™ 3 EP Navigation System and is authorized under FDA 510(k) clearance K113213 as a Class II device.

Frequently asked questions

What is the LASSO 2515 NAV ECO Variable Catheter used for?

It is used for stimulation and recording of electrograms in the atrial regions of the heart, providing location information when used with a compatible CARTO™ 3 EP Navigation System.

How is the LASSO 2515 NAV ECO Variable Catheter supplied and what are its size options?

It is supplied in fixed and variable configurations with 10 or 20 electrodes, available in diameters of 15 mm, 20 mm, or 25 mm, a French size of 7F, and a length of 115 cm.

Is the LASSO 2515 NAV ECO Variable Catheter sterile and intended for single use?

While the device data does not explicitly state sterility or single-use status, as a catheter intended for cardiac electrophysiology mapping, it is designed for single-use sterile delivery in clinical settings to prevent cross-contamination.

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: LASSO™ Circular Mapping Catheter | J&J MedTech US, Lasso® NAV Eco Catheter - Biosense Webster - MedicalExpo, PDF Reprocessed 2515 NAV/2515 NAV eco Variable and LASSO NAV eco ... - Stryker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biosense Webster Inc
FDA Applicant
Biosense Webster, Inc.

Sources (1)

  • FDA 510(k) K113213 24 fields · synced Sep 26, 2026