LWQ · Heart-Valve, Mechanical
· Class 3
Overview
| Product Code | LWQ |
|---|---|
| Device Name | Heart-Valve, Mechanical |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P000037 | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA | On-X Life Technologies, Inc. | May 30, 2001 | APPR |
| P990046 | ATS OPEN PIVOT BILEAFLET HEART VALVE | Medtronic Ats Medical, Inc. | Oct 13, 2000 | APPR |
| P970002 | MONOSTRUT CARDIAC VALVE PROSTHESIS | Alliance Medical Technologies, Inc. | Sep 30, 1997 | APPR |
| P900060 | CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) | Corcym S.r.l. | Sep 29, 1993 | APPR |
| P870038 | STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES | Edwards Lifesciences, LLC | Sep 27, 1991 | APWD |
| P850006 | DUROMEDICS BILEAFLET HEART VALVE | Edwards Lifesciences, LLC | Aug 29, 1986 | APWD |
| P830039 | OMNISCEINCE PROSTHETIC CARDIAC VALVE | Medical Cv, Inc. | May 3, 1985 | APWD |
| P810002 | BILEAFLET-CENTER OPENING CARDIAC VALVE | ABBOTT MEDICAL | Dec 17, 1982 | APPR |
| P790018 | MEDTRONIC(R) HALL PROSTHETIC HEART VALVE | Medtronic Cardiac Surgery | Dec 23, 1981 | APWD |
Top Applicants
- Edwards Lifesciences, LLC — 2 clearances
- ABBOTT MEDICAL — 1 clearance
- Alliance Medical Technologies, Inc. — 1 clearance
- Corcym S.r.l. — 1 clearance
- Medical Cv, Inc. — 1 clearance
