Name: Predicase
Price: 199 USD

K-number	K220258
Device name	20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
Applicant	Avia Vascular
Product code	JKA
Device class	Class II
Decision date	Jul 14, 2022
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

Everything you need for a 510(k) submission. Nothing you don't.