MOP · Rotator, Prosthetic Heart Valve
Cardiovascular · 21 CFR 870.3935 · Class 1
Overview
| Product Code | MOP |
|---|---|
| Device Name | Rotator, Prosthetic Heart Valve |
| Regulation | 21 CFR 870.3935 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | Aug 7, 1998 | SESE |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | Aug 4, 1998 | SESE |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | Apr 29, 1996 | SESE |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | Jun 20, 1995 | SESE |
Top Applicants
- Carbomedics, Inc. — 2 clearances
- Genzyme Surgical Product (Genzyme Biosurgery) — 1 clearance
- Sulzer Carbomedics, Inc. — 1 clearance
