510(k) K994216 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Dec 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24 Open, Classified |
LJT | None listed |
| Mar 18, 2025 | Smiths Medical ASD, Inc. smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24 Open, Classified |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4155-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24 Terminated |
LJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.