Name: Predicase
Price: 199 USD

K-number	K183615
Device name	Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Applicant	Avenu Medical, Inc.
Product code	PQK
Device class	Class II
Decision date	Jan 25, 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), Crossing Needle

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