Company ยท US
Deltec, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2003. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
28recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 18 |
| DYB | Introducer, Catheter | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 |
| FPA | Set, Administration, Intravascular | 2 |
| LZG | Pump, Infusion, Insulin | 2 |
| FRN | Pump, Infusion | 1 |
| LNY | Catheter, Percutaneous, Long Term, Intraspinal | 1 |
| MDV | 1 | |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 2003 | K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP Deltec, Inc. | FPA |
| Apr 25, 2003 | K030983 | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY Deltec, Inc. | MSD |
| Jan 30, 2003 | K022221 | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS Deltec, Inc. | MPB |
| Aug 13, 2002 | K021999 | GRIPPER PLUS NEEDLE Deltec, Inc. | FPA |
| Aug 13, 2002 | K020655 | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES Deltec, Inc. | LZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm I.D., 10 French Introducer Set, REF 21-8068-24 Terminated |
LJT | K974471 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24 Terminated |
LJT | K974471 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24 Terminated |
LJT | K962695 |
| 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 | K994216 |
| 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 | K994216 |
| 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 | K994216 |
| 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 | K994216 |
| 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 | K994216 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24 Terminated |
LJT | K962695 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Polysulfone/Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4051-24 Terminated |
LJT | K932840 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24 Terminated |
LJT | K973862 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24 Terminated |
LJT | K973862 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4009-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4003-24 Terminated |
LJT | None listed |
| Jul 20, 2004 | Deltec, Inc 8.5 Fr Introducer Set, REF 21-2370-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Deltec, Inc 9 Fr Introducer Set, REF 21-2340-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Deltec, Inc 6 Fr Introducer Set, REF 21-2320-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22 Terminated |
MDV | None listed |
| Jul 20, 2004 | Deltec, Inc Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01 Terminated |
LNY | None listed |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107 Terminated |
FOZ | K904334 |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106 Terminated |
FOZ | K904334 |
| Jul 30, 2003 | Deltec, Inc Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105 Terminated |
FOZ | K904334 |
| Jul 3, 2003 | Deltec, Inc Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software Terminated |
FRN | K000842 |
| May 9, 2003 | Deltec, Inc Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior. Terminated |
LZG | K020655 |