Name: Predicase
Price: 199 USD

K-number	K191114
Device name	Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Applicant	Avenu Medical
Product code	PQK
Device class	Class II
Decision date	Aug 9, 2019
Decision	Substantially Equivalent
Regulation	870.1252

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Source

View the full FDA submission: accessdata.fda.gov

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Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

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