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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
Avalus™ — MEDTRONIC, INC.Duran AnCore — MEDTRONIC, INC.Masters Series™ — ST. JUDE MEDICAL, INC.HEART VALVE ACCESSOR — Edwards Lifesciences LLCOpen Pivot™ — MEDTRONIC, INC.Annuloplasty Handle — MEDTRONIC, INC.Valve Handle — MEDTRONIC, INC.Masters Series™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Valve Handle — MEDTRONIC, INC.Regent™ — ST. JUDE MEDICAL, INC.Open Pivot™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.Valve Handle — MEDTRONIC, INC.NA — MEDTRONIC, INC.Avalus™ — MEDTRONIC, INC.HEART VALVE ACCESSOR — Edwards Lifesciences LLCSJM™ — ST. JUDE MEDICAL, INC.Annuloplasty Handle — MEDTRONIC, INC.Annuloplasty Handle — MEDTRONIC, INC.NA — MEDTRONIC, INC.MITRIS Handle 1140M — Edwards Lifesciences LLCSJM™ — ST. JUDE MEDICAL, INC.HEART VALVE HANDLE ACCESSORY — Edwards Lifesciences LLC
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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