Product code LWQ ยท Class 3
Heart-Valve, Mechanical
0510(k)s in 12 months (0 all time)
1recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in LWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| CryoLife, Inc. | 0 | 2 |
| ATS Medical, Inc. | 0 | 1 |
| MEDTRONIC ATS MEDICAL, INC. | 0 | 1 |
| On-X Life Technologies, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | On-X Life Technologies, Inc. On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 Open, Classified |
LWQ | None listed |
| Feb 11, 2020 | MEDTRONIC ATS MEDICAL, INC. Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Terminated |
LWQ | None listed |
| Jan 17, 2019 | CryoLife, Inc. On-X Aortic Heart Valve with Anatomic Sewing Ring
Product Usage:
The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart va Terminated |
LWQ | None listed |
| Jun 12, 2015 | CryoLife, Inc. On-X Prosthetic Heart Valve
Product Usage:
Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions Terminated |
LWQ | None listed |
| Jul 20, 2004 | ATS Medical, Inc. ATS Open Pivot Mechanical Heart Valve Terminated |
LWQ | None listed |
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