Class Class II

Edwards eSheath Optima introducer set (K252364)

K252364 2025-08-29 Special
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Description

Edwards eSheath Optima introducer set by Edwards Lifesciences, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252364
Clearance Date2025-08-29
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340

Categories

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