Class Class II

ProtekDilate Vascular Access Kit (K253616)

K253616 2025-12-19 Special
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Description

ProtekDilate Vascular Access Kit by Sorin Group Italia S.R.L., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253616
Clearance Date2025-12-19
Clearance TypeSpecial
Product CodeDRE
Regulation Number870.1310

Categories

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