MFY · Endothelial Cell Harvesting Kit
Cardiovascular · 21 CFR 870.4075 · Class 2
Overview
| Product Code | MFY |
|---|---|
| Device Name | Endothelial Cell Harvesting Kit |
| Regulation | 21 CFR 870.4075 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925608 | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT | Scimed Life Systems, Inc. | Jun 16, 1993 | SESK |
Top Applicants
- Scimed Life Systems, Inc. — 1 clearance
