510(k) DEN170004
- Device
- Ellipsys Vascular Access System
- Applicant
- Avenu Medical, Inc.
- 510(k) number
- DEN170004
- Product code
- PQK
- Decision
- Unknown (DENG)
- Decision date
- 2018-06-22
- Date received
- 2017-01-10
- Regulation
- 870.1252
- Classification name
- Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rebecca K. Pine
- Address
- 27123 Calle Arroyo, Suite 2101 San Juan Capistrano CA US 92675 92675
FDA Registration Numbers#
- 9616666
- 2020394
- 2030624
- 2183744
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192239 | WavelinQ Plus EndoAVF System | C.R. Bard, Inc. | 2019-10-17 |
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | Avenu Medical | 2019-08-09 |
| K182796 | WavelinQ 4F EndoAVF System | C.R. Bard, Inc. | 2019-02-06 |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | Avenu Medical, Inc. | 2019-01-25 |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | Avenu Medical, Inc. | 2018-10-05 |
| DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | 2018-06-22 |