Name: Predicase
Price: 199 USD

K-number	K202141
Device name	Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
Applicant	Argon Medical Devices, Inc.
Product code	DYB
Device class	Class II
Decision date	Jan 15, 2021
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

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