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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: 04/19/2024
 
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carto 3 ep navigation system version 7.2 Biosense Webster, Inc. K213264 10/29/2021
carto 3 ep navigation system with advanced focus mapping (afm) Biosense Webster, Inc. K221112 08/17/2022
carto 3 ep navigation system, v1.0 and accessories BIOSENSE WEBSTER, INC. K090017 10/13/2009
carto 3 ep navigation system, version 2.0 (w/standard location pad),carto3 epnavigation system,version 2.0 w/rmt pad) BIOSENSE WEBSTER, INC. K103746 01/21/2011
carto 3 ep navigation system, version 2.2 BIOSENSE WEBSTER, INC. K112007 10/05/2011
carto 3 ep navigation system, version 4.2 BIOSENSE WEBSTER, INC. K133916 07/01/2014
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 5.2 and accessories with cartofinder module Biosense Webster, Inc. K173978 08/24/2018
carto 3 ep navigation system, version 6.0 and accessories Biosense Webster, Inc. K170600 07/25/2017
carto 3 ep navigation system, version 6.0 and accessories with visitag surpoint Biosense Webster, Inc. K180238 06/01/2018
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