Name: Predicase
Price: 199 USD

K-number	K201489
Device name	Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
Applicant	Argon Medical Devices, Inc.
Product code	DYB
Device class	Class II
Decision date	Dec 22, 2020
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

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