Device |
interventional cardiovascular implant simulation software device |
Regulation Description |
Interventional cardiovascular implant simulation software device. |
Definition |
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment. |
Physical State |
Software device |
Technical Method |
The device performs simulation by combining a predefined device model with a patient-specific model of the patient anatomy. |
Target Area |
Left atrial appendage |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QQI |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.1405
|
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 |