510(k) K050310 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
BARDPORT TITANIUM PORTS
| Applicant | Bard Access Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 18, 2005 |
| Received | Feb 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Bard Peripheral Vascular Inc BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563
Product Usage: Bard implantable ports are indicated for patient Terminated |
LJT | None listed |
| Sep 8, 2011 | Bard Access Systems BardPort Titanium Implanted Port.
Bard Access Systems.
Assembled in Mexico.
A totally implantable vascular access device designed to provide long term repeated access to the vascular system Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.