| Device Type ID | 811 |
| Device Name | Device, Biopsy, Endomyocardial |
| Regulation Description | Endomyocardial Biopsy Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4075 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 811 |
| Device | Device, Biopsy, Endomyocardial |
| Product Code | DWZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endomyocardial Biopsy Device. |
| CFR Regulation Number | 870.4075 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GERALD FEHLING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Packaging Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 5 |