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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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noga xp cardiac navigation system with qwikmap software BIOSENSE WEBSTER, INC. K053194 03/09/2006
noga cardiac navigation system BIOSENSE WEBSTER, INC. K000332 05/04/2000
modification to carto ep navigation system BIOSENSE WEBSTER, INC. K000190 05/05/2000
modification to carto ep navigation system BIOSENSE WEBSTER, INC. K993729 12/03/1999
carto3 ep navigation system, version 3.2 BIOSENSE WEBSTER, INC. K132782 01/24/2014
carto® 3 ep navigation system with signal processing unit Biosense Webster, Inc. K200484 11/25/2020
carto® 3 ep navigation system with cartosound™ 4d version 7.4 Biosense Webster, Inc. K223733 02/16/2023
carto™ 3 ep navigation system software v8.0 (fg-5400-00, fg-5400-00u) Biosense Webster, Inc. K231207 09/07/2023
carto(r) ep navigation system, version 3.0 (with standard location pad) BIOSENSE WEBSTER, INC. K120550 05/07/2012
carto xp ep navigation system, version 9 BIOSENSE WEBSTER, INC. K070240 05/04/2007
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