Class Class II

Genie MAX Large Bore Introducer Sheath (K253652)

K253652 2026-01-22 Traditional
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Description

Genie MAX Large Bore Introducer Sheath by Cultiv8 1, LLC, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253652
Clearance Date2026-01-22
Clearance TypeTraditional
Product CodeDYB
Regulation Number870.1340

Categories

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