510(k) K182796 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
WavelinQ 4F EndoAVF System
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Feb 6, 2019 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2019 | Bard Peripheral Vascular Inc BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S005 Terminated |
PQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.