Home › Device types › DTI
Sizer, Heart-Valve, Prosthesis
FDA product code DTI · Class 1 · Cardiovascular
302
Registered devices
200
Adverse events
2
Recalls
7
510(k) clearances
Devices with this code
Medtronic Open Pivot™ — MEDTRONIC, INC.SIZER FOR MODEL 5200 PHYSIO II RING — Edwards Lifesciences LLCSimuPlus™ — MEDTRONIC, INC.MOSAIC ULTRA™ — MEDTRONIC, INC.Trifecta™ — ST. JUDE MEDICAL, INC.Trifecta™ — ST. JUDE MEDICAL, INC.CG Future™ — MEDTRONIC, INC.On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.HEART VALVE SIZER ACCESSORY — Edwards Lifesciences LLCSIZER FOR MODEL 5200 PHYSIO II RING — Edwards Lifesciences LLCBARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE — Edwards Lifesciences LLCBARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE — Edwards Lifesciences LLCMOSAIC™CINCH™ — MEDTRONIC, INC.HEART VALVE ACCESSORY OBTURATOR FOR MITRAL XENOGRAFT 25MM — Edwards Lifesciences LLCHancock™ II 7505 — MEDTRONIC, INC.AORTIC TRUE-SIZE OBTURATOR 21MM — Edwards Lifesciences LLCPERIMOUNT MAGNA EASE AORTIC SIZER 21MM — Edwards Lifesciences LLCOn-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.Tailor™ & Attune™ — ST. JUDE MEDICAL, INC.Epic™ — ST. JUDE MEDICAL, INC.EDWARDS INTUITY SIZER — Edwards Lifesciences LLCOn-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.AORTIC TRUE-SIZE OBTURATOR 19MM — Edwards Lifesciences LLCSJM™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) coul |
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) coul |
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