MODIFICATION TO T-REX BIOPSY FORCEPS
Device Facts
| Record ID | K000409 |
|---|---|
| Device Name | MODIFICATION TO T-REX BIOPSY FORCEPS |
| Applicant | Boston Scientific Corp |
| Product Code | DWZ · Cardiovascular |
| Decision Date | Feb 28, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.4075 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.