The following data is part of a premarket notification filed by Avenu Medical, Inc. with the FDA for Ellipsys Vascular Access System (ellipsys System), (power Controller Model No. Ami-1001 & Catheter & Needle Model No. Ami-6005).
Device ID | K181725 |
510k Number | K181725 |
Device Name: | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) |
Classification | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
Applicant | Avenu Medical, Inc. 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 |
Contact | Rebecca K. Pine |
Correspondent | Rebecca K. Pine Avenu Medical, Inc. 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 |
Product Code | PQK |
CFR Regulation Number | 870.1252 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-29 |
Decision Date | 2018-10-05 |
Summary: | summary |