Panels › Cardiovascular › Product code PQK · Class 2
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Regulation 870.1252
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PQK
| Company | 510(k)s | Recalls |
|---|---|---|
| Avenu Medical | 4 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Bard Peripheral Vascular Inc | 0 | 1 |
| Tva Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2019 | K192239 | WavelinQ Plus EndoAVF System C.R. Bard, Inc. | PQK |
| Aug 9, 2019 | K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Avenu Medical | PQK |
| Feb 6, 2019 | K182796 | WavelinQ 4F EndoAVF System C.R. Bard, Inc. | PQK |
| Jan 25, 2019 | K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Avenu Medical, Inc. | PQK |
| Oct 5, 2018 | K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AM Avenu Medical, Inc. | PQK |
| Jun 22, 2018 | DEN170004 | Ellipsys Vascular Access System Avenu Medical, Inc. | PQK |
| Jun 22, 2018 | DEN160006 | everlinQ endoAVF System Tva Medical, Inc. | PQK |
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