DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
Device Facts
| Record ID | K951447 |
|---|---|
| Device Name | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS |
| Applicant | Portlyn Corp. |
| Product Code | DWZ · Cardiovascular |
| Decision Date | Jul 27, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.