Class Class II

CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085)

K254085 2026-01-18 Special
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Description

CARTO™ 3 EP Navigation System V9.0 with PIU Plus by Biosense Webster, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK254085
Clearance Date2026-01-18
Clearance TypeSpecial
Product CodeDQK
Regulation Number870.1425

Categories

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