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Holder, Heart-Valve, Prosthesis
FDA product code DTJ · Class 1 · Cardiovascular
47
Registered devices
2
Adverse events
1
Recalls
12
510(k) clearances
Devices with this code
Annuloplasty Handle — MEDTRONIC, INC.Annuloplasty Handle — MEDTRONIC, INC.Masters Series™ — ST. JUDE MEDICAL, INC.Avalus™ — MEDTRONIC, INC.SJM™ — ST. JUDE MEDICAL, INC.A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 — Edwards Lifesciences LLCNA — MEDTRONIC, INC.CARBOMEDICS PROSTHETIC HEART VALVES — CORCYM SRLSJM Regent™ — ST. JUDE MEDICAL, INC.SJM™ — ST. JUDE MEDICAL, INC.Annuloplasty Handle — MEDTRONIC, INC.1141M MITRIS RESILIA Mitral Valve Handle — Edwards Lifesciences LLCNA — MEDTRONIC, INC.Annuloplasty Handle — MEDTRONIC, INC.NA — MEDTRONIC, INC.Valve Handle — MEDTRONIC, INC.Valve Handle 7420 — MEDTRONIC, INC.Valve Handle — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.SJM™ — ST. JUDE MEDICAL, INC.Profile 3D™ — MEDTRONIC, INC.Annuloplasty Handle — MEDTRONIC, INC.NA — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-04-30 | Carbomedics, Inc | Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. |
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