Name: Predicase
Price: 199 USD

K-number	K181725
Device name	Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Applicant	Avenu Medical, Inc.
Product code	PQK
Device class	Class II
Decision date	Oct 5, 2018
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 Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

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