FDA 510(k)

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

K-Number: K231207 · 2023-09-07

Decision Date2023-09-07

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-09-07 under approval number K231207. 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 Software V8.0 (FG-5400-00, FG-5400-00U)?

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is a medical device that received FDA 510(k) clearance on 2023-09-07. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K231207.

When was CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) approved by the FDA?

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) received FDA 510(k) clearance on 2023-09-07, under approval number K231207.

What company makes CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)?

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)?

The FDA product code for CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is DQK.

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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

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Official Source

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