Name: Predicase
Price: 199 USD

K-number	K213602
Device name	Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Applicant	Covidien, LLC
Product code	FJS
Device class	Class II
Decision date	Jan 14, 2022
Decision	Substantially Equivalent
Regulation	876.5630

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Source

View the full FDA submission: accessdata.fda.gov

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Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

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