510(k) K072549 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Nov 14, 2007 |
| Received | Sep 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Bard Peripheral Vascular Inc 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482
Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated acc Terminated |
LJT | None listed |
| Apr 29, 2010 | Bard Access Systems PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico
Indicated for pati Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.