510(k) K022983 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
BARDPORT X-PORT ISP PORT
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 25, 2002 |
| Received | Sep 9, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Bard Peripheral Vascular Inc 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195
2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F O Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.