Definition: This Device Is Intended For Closure Of Cardiac Apical Tissue.
| Device Type ID | 974 |
| Device Name | Apical Closure Device |
| 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 Description | Apical Closure Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 974 |
| Device | Apical Closure Device |
| Product Code | PNQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Apical Closure Device. |
| CFR Regulation Number | 870.4510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MICRO INTERVENTIONAL DEVICES, INC. | ||
GRANTED | 1 | |