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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 31 Results
ProductCode: DQK Applicant: Biosense Webster, Inc. Decision Date To: 10/31/2024
 
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carto™ 3 ep navigation system software v8.0 (fg-5400-00, fg-5400-00u) Biosense Webster, Inc. K231207 09/07/2023
carto® 3 ep navigation system with cartosound™ 4d version 7.4 Biosense Webster, Inc. K223733 02/16/2023
carto 3 ep navigation system with advanced focus mapping (afm) Biosense Webster, Inc. K221112 08/17/2022
carto 3 ep navigation system version 7.2 Biosense Webster, Inc. K213264 10/29/2021
carto® 3 ep navigation system with signal processing unit Biosense Webster, Inc. K200484 11/25/2020
carto 3 ep navigation system, version 7.1 and accessories Biosense Webster, Inc. K191660 07/20/2019
carto 3 ep navigation system, version 5.2 and accessories with cartofinder module Biosense Webster, Inc. K173978 08/24/2018
carto 3 ep navigation system, version 4.35 and accessories with coherent map module Biosense Webster, Inc. K173977 06/14/2018
carto 3 ep navigation system, version 6.0 and accessories with visitag surpoint Biosense Webster, Inc. K180238 06/01/2018
carto 3 ep navigation system, version 6.0 and accessories Biosense Webster, Inc. K170600 07/25/2017
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