510(k) K063377 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 25, 2007 |
| Received | Nov 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2019 | Bard Peripheral Vascular Inc PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Open, Classified |
LJT | None listed |
| Jun 25, 2018 | Bard Peripheral Vascular Inc POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit;
POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit;
POWERPORT CLEARVUE Slim, 6F CHRONOF Completed |
LJT | None listed |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362 Completed |
LJT | None listed |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362 Completed |
LJT | None listed |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362 Completed |
LJT | None listed |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362 Completed |
LJT | None listed |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004 Completed |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.