FDA 510(k) Applications for Medical Device Product Code "PQK"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191114 | Avenu Medical | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | 08/09/2019 |
| DEN170004 | Avenu Medical, Inc | Ellipsys Vascular Access System | 06/22/2018 |
| K181725 | Avenu Medical, Inc. | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | 10/05/2018 |
| K183615 | Avenu Medical, Inc. | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | 01/25/2019 |
| K182796 | C. R. Bard, Inc. | WavelinQ 4F EndoAVF System | 02/06/2019 |
| K192239 | C.R. Bard, Inc. | WavelinQ Plus EndoAVF System | 10/17/2019 |
| DEN160006 | TVA Medical, Inc. | everlinQ endoAVF System | 06/22/2018 |
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