Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle— 510(k) K191114
Substantially EquivalentAvenu Medical
FDA 510(k) clearance K191114 for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle, Substantially Equivalent on 2019-08-09. Applicant: Avenu Medical. Device class: 2.
Clearance details
- Applicant
- Avenu Medical
- Product code
- Code PQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1252
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code PQK
view all- K192239 — WavelinQ Plus EndoAVF System
- 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)
- DEN160006 — everlinQ endoAVF System
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.