| Device |
reverse central venous recanalization system |
| Regulation Description |
Reverse central venous recanalization system. |
| Definition |
A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods. |
| Physical State |
Delivery system with a distal needle-wire component and system accessories. |
| Technical Method |
Uses a delivery device to gain venous access, advance the system to the site of the occlusion and advance a wire from the vein to the skin. Conventional methods are then used to place a central venous catheter over the wire. |
| Target Area |
Central veins and supra-clavicular space. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QJH |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1342
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
