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On-X Heart Valve Instruments
ON-X LIFE TECHNOLOGIES, INC. · Model ONXI2-19S · UDI-DI 00851788001082
DTI
Prescription
7
510(k) clearances
203
Adverse events
2
Recalls
23
Facilities
Description
Aortic SIzers for valve size 19 (grey). The sizers are used to gauge the resulting tissue annulus diameter after the annulus is prepared for implant.
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) could have come in conta |
| 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) could have come in conta |
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