Home › Device types › DTI
Sizer, Heart-Valve, Prosthesis
FDA product code DTI · Class 1 · Cardiovascular
311
Registered devices
203
Adverse events
2
Recalls
7
510(k) clearances
Devices with this code
On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.HEART VALVE SIZER ACCESSORY — Edwards Lifesciences LLCBARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE — Edwards Lifesciences LLCHancock™ II 7510 — MEDTRONIC, INC.HEART VALVE ACCESSORY — Edwards Lifesciences LLCHEART VALVE ACCESSORY — Edwards Lifesciences LLCNA — Fehling Instruments GmbH & Co. KGEDWARDS INTUITY ELITE AORTIC SIZER 25 — Edwards Lifesciences LLCOn-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.Tailor™ & Attune™ — ST. JUDE MEDICAL, INC.AORTIC TRUE-SIZE OBTURATOR 29MM — Edwards Lifesciences LLCHEART VALVE ACCESSOR — Edwards Lifesciences LLCHEART VALVE SIZER ACCESSORY — Edwards Lifesciences LLCPERIMOUNT MAGNA EASE AORTIC SIZER 29MM — Edwards Lifesciences LLCNA — ST. JUDE MEDICAL, INC.CG Future™ — MEDTRONIC, INC.NA — ST. JUDE MEDICAL, INC.PERIMOUNT MAGNA EASE AORTIC SIZER 21MM — Edwards Lifesciences LLCPHYSIO TRICUSPID SIZER — Edwards Lifesciences LLCOn-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.Open Pivot™ — MEDTRONIC, INC.NA — ST. JUDE MEDICAL, INC.NA — ST. JUDE MEDICAL, INC.HEART VALVE ACCESSORY — Edwards Lifesciences LLC
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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