Class Class II

EnSite™ X EP System (K252013)

K252013 2025-09-25 Traditional
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Description

EnSite™ X EP System by Abbott Medical, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252013
Clearance Date2025-09-25
Clearance TypeTraditional
Product CodeDQK
Regulation Number870.1425

Categories

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