PRIMI SUPPORT CATHETER
THERMOPEUTIX INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005034471 | 3005034471 | THERMOPEUTIX INC. | 1 | N | 2020-04-25 | 9951 Businesspark Ave Ste B SAN DIEGO CA US 92131 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M781DF80115801 | TwinFlo™ Catheter - The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lumens, IFL and OFL) that can infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are two additional smaller lumens; one lumen is used for inflation of the distal balloon on the inflow lumen while the second small lumen permits pressure monitoring distal to the balloon. Inflation of the balloon isolates the region distal to the balloon permitting infusion into the vascular region of interest. When used to provide perfusion or control blood flow, blood exits via the outflow lumen to an extracorporeal circuit and is returned via the inflow lumen distal to the inflated balloon. The catheter is supplied with hydrophilic coating. | 1-858-549-1760 | customer.service@thermopeutix.com |
| M781DFH10115801 | TwinFlo™ Catheter - The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lumens, IFL and OFL) that can infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are two additional smaller lumens; one lumen is used for inflation of the distal balloon on the inflow lumen while the second small lumen permits pressure monitoring distal to the balloon. Inflation of the balloon isolates the region distal to the balloon permitting infusion into the vascular region of interest. When used to provide perfusion or control blood flow, blood exits via the outflow lumen to an extracorporeal circuit and is returned via the inflow lumen distal to the inflated balloon. The catheter is supplied with heparin in the hydrophilic coating. | 1-858-549-1760 | customer.service@thermopeutix.com |
| M781DFH10115901 | TwinFlo™ Catheter - The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lumens, IFL and OFL) that can infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are two additional smaller lumens; one lumen is used for inflation of the distal balloon on the inflow lumen while the second small lumen permits pressure monitoring distal to the balloon. Inflation of the balloon isolates the region distal to the balloon permitting infusion into the vascular region of interest. When used to provide perfusion or control blood flow, blood exits via the outflow lumen to an extracorporeal circuit and is returned via the inflow lumen distal to the inflated balloon. The catheter is supplied with heparin in the hydrophilic coating. | 1-858-549-1760 | customer.service@thermopeutix.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 64697 | 1047887825 | K130850 | PRIMI AND SECONDI SUPPORT CATHETERS | DQY | 2013-06-25 |
| 64697 | 1165544523 | K112219 | TAPAS CATHETER | MJN | 2011-11-18 |
| 64697 | 1515360132 | K093847 | DUFLO CATHETER (HEPARIN COATED) | MJN | 2010-08-25 |
| 64697 | 1348049795 | K080700 | DUOFLO CATHETER | MJN | 2008-09-26 |
THERMOPEUTIX INC.
THERMOPEUTIX INC.
THERMOPEUTIX INC.
THERMOPEUTIX INC.
THERMOPEUTIX INC.
THERMOPEUTIX INC. DBA YMED INC.
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-19
2016-09-15
2016-09-15
2016-09-15
2016-09-19
2016-09-19