MOPClass I
Rotator, Prosthetic Heart Valve
Cardiovascular · 21 CFR 870.3935
MDR events3All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances4All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Injury1
Malfunction1
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
4 clearances for this product code
- Genzyme Surgical Product (Genzyme Biosurgery)Aug 7, 1998
K980016 · MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
- Sulzer Carbomedics, Inc.Aug 4, 1998
K974648 · SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
- Carbomedics, Inc.Apr 29, 1996
K960923 · CARBOMEDICS MITRAL ROTATOR
- Carbomedics, Inc.Jun 20, 1995
K951368 · CARBOMEDICS EXENDED MITRAL ROTATOR