510(k) K183615
- Device
- Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
- Applicant
- Avenu Medical, Inc.
- 510(k) number
- K183615
- Product code
- PQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-25
- Date received
- 2018-12-26
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dave Campbell
- Address
- 27123 Calle Arroyo, Suite 2101 San Juan Capistrano CA US 92675 92675
FDA Registration Numbers#
- 9616666
- 2020394
- 2030624
- 2183744
Source Documents#
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 |
| 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 |
| DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | 2018-06-22 |
Legacy Summary#
summary
FDA Review#
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