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FDA 510(k)

CARTO® 3 EP Navigation System with Signal Processing Unit

K-Number: K200484 · 2020-11-25

ApplicantBiosense Webster, Inc.
Decision Date2020-11-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO® 3 EP Navigation System with Signal Processing Unit is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2020-11-25 under approval number K200484. 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 with Signal Processing Unit?

CARTO® 3 EP Navigation System with Signal Processing Unit is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K200484.

When was CARTO® 3 EP Navigation System with Signal Processing Unit approved by the FDA?

CARTO® 3 EP Navigation System with Signal Processing Unit received FDA 510(k) clearance on 2020-11-25, under approval number K200484.

What company makes CARTO® 3 EP Navigation System with Signal Processing Unit?

CARTO® 3 EP Navigation System with Signal Processing Unit is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO® 3 EP Navigation System with Signal Processing Unit?

The FDA product code for CARTO® 3 EP Navigation System with Signal Processing Unit is DQK.

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) 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) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (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 K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories

View all 33 devices →

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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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