510(k) K163001 ยท PTD Subcutaneous Implanted Apheresis Port
PowerFlow Apheresis I.V. Port
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Apr 17, 2017 |
| Received | Oct 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Bard Peripheral Vascular Inc PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl
x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438
Product Usage: Bard implantable ports are indicated Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.