FDA Product Code
FDA Product Code PQK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1252
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192239 | WavelinQ Plus EndoAVF System | C.R. Bard, Inc. | 2019-10-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K182796 | WavelinQ 4F EndoAVF System | C.R. Bard, Inc. | 2019-02-06 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | 2018-06-22 | Direct | — |
| DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | 2018-06-22 | Direct | — |
Product code PQK · Class II · Cardiovascular. Data: openFDA.