Class Class II

Primero Safe Access System (K252441)

K252441 2025-09-29 Traditional
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Description

Primero Safe Access System by South53, LLC, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252441
Clearance Date2025-09-29
Clearance TypeTraditional
Product CodeDYB
Regulation Number870.1340

Categories

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