Class Class II

HemoSphere Stream Module (K253034)

K253034 2025-10-21 Special
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Description

HemoSphere Stream Module by Edwards Lifesciences, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253034
Clearance Date2025-10-21
Clearance TypeSpecial
Product CodeDQK
Regulation Number870.1425

Categories

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