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FDA 510(k)

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

K-Number: K173977 · 2018-06-14

ApplicantBiosense Webster, Inc.
Decision Date2018-06-14
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K173977. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module?

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K173977.

When was CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module approved by the FDA?

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module received FDA 510(k) clearance on 2018-06-14, under approval number K173977.

What company makes CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module?

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module?

The FDA product code for CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is DQK.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Biosense Webster, Inc.

K170997CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath K170600CARTO 3 EP Navigation System, Version 6.0 and Accessories K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories K200484CARTO® 3 EP Navigation System with Signal Processing Unit

View all 33 devices →

Related Devices (Code: DQK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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