Device |
apical closure device |
Regulation Description |
Apical closure device. |
Definition |
This device is intended for closure of cardiac apical tissue. |
Physical State |
The device is composed of a suture and polymeric anchor system that is placed in cardiac apical tissue using a delivery system. |
Technical Method |
This device deploys an anchor and suture system into cardiac apical tissue to form an operative window through which apical access can be gained. The device is also used to close the opening. |
Target Area |
Cardiac apical tissue |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PNQ |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.4510
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |