Ellipsys Vascular Access System— 510(k) DEN170004
UnknownAvenu Medical, Inc.
FDA 510(k) clearance DEN170004 for Ellipsys Vascular Access System, Unknown on 2018-06-22. Applicant: Avenu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avenu Medical, Inc.
- Product code
- Code PQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1252
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- San Juan Capistrano, CA, US
Recent devices under product code PQK
view all- K192239 — WavelinQ Plus EndoAVF System
- K191114 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
- K182796 — WavelinQ 4F EndoAVF System
- K183615 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
- K181725 — Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Adverse events under product code PQK
product code PQK- Death
- 7
- Injury
- 191
- Total
- 198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.