The following data is part of a premarket notification filed by Avenu Medical with the FDA for Ellipsys Vascular Access System (ellipsys System), Power Controller, Ellipsys Vascular Access System (ellipsys System), Catheter, Ellipsys Vascular Access System (ellipsys System), Needle.
| Device ID | K191114 |
| 510k 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 |
| Classification | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Applicant | Avenu Medical 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 |
| Contact | Dave Campbell |
| Correspondent | Dave Campbell Avenu Medical 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 | 2019-04-26 |
| Decision Date | 2019-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000478193 | K191114 | 000 |
| 00763000496982 | K191114 | 000 |
| 00763000496975 | K191114 | 000 |
| 00763000574710 | K191114 | 000 |