SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
Device Facts
| Record ID | K925608 |
|---|---|
| Device Name | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT |
| Applicant | Scimed Life Systems, Inc. |
| Product Code | MFY · Cardiovascular |
| Decision Date | Jun 16, 1993 |
| Decision | SESK |
| 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.
