510(k) K192239 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
WavelinQ Plus EndoAVF System
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | Aug 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.