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MODIFICATION TO CARTO EP NAVIGATION SYSTEM — Biosense Webster, Inc. (510(k) K000190)

MODIFICATION TO CARTO EP NAVIGATION SYSTEM — Biosense Webster, Inc. (510(k) K000190) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFICATION TO CARTO EP NAVIGATION SYSTEM; Applicant: Biosense Webster, Inc.; Clearance track: 510(k).

Device nameMODIFICATION TO CARTO EP NAVIGATION SYSTEM
ApplicantBiosense Webster, Inc.
Clearance track510(k)
Submission numberK000190
DecisionSubstantially Equivalent
Decision date2000-05-05
Date received2000-01-13
Product codeDQK
Device class2
Medical specialtyCardiovascular
Applicant locationCA, US
SourceopenFDA device

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