Device |
reprocessed catheter introducer |
Regulation Description |
Catheter introducer. |
Definition |
Introduce various cardiovascular catheters into the heart and cardiovascular system |
Physical State |
Sheath with lumen(s). Polymer-based shaft material for both introducer and dilator. Reprocessed device. |
Technical Method |
The devices navigate to the target location and facilitate the introduction of cardiovascular catheters to the target location. |
Target Area |
Heart and vasculature (coronary and peripheral) |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PNE |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.1340
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |