Definition: Intended To Occlude The Left Atrial Appendage.
| Device Type ID | 1003 |
| Device Name | Left Atrial Appendage Clip, Implantable |
| Physical State | A Clip-like Device That Compresses The Left Atrial Appendage. |
| Technical Method | Epicardially Applied During A Concomitant Surgical Procedure To Physically Occlude The Left Atrial Appendage. |
| Target Area | Left Atrial Appendage Of The Heart. |
| Regulation Description | Implantable Clip. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1003 |
| Device | Left Atrial Appendage Clip, Implantable |
| Product Code | PZX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Clip. |
| CFR Regulation Number | 878.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATRICURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |