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 |