# Avenu Medical, Inc.

- Location (FDA's records): San Juan Capistrano, CA
- FDA decisions: 4 (2018–2019): 3 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Avenu Medical, Inc. (3); Avenu Medical (1)
- Product codes: PQK (4)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN170004: Ellipsys Vascular Access System (2018), cited by 1
- K181725: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (2018), cited by 1
- K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (2019), cited by 1

## Recent decisions
- K191114: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (Aug 9, 2019)
- K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (Jan 25, 2019)
- K181725: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (Oct 5, 2018)
- DEN170004: Ellipsys Vascular Access System (Jun 22, 2018)

Source page: https://510kreport.com/company/avenu-medical