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| Product | Model | Company | Device type |
|---|---|---|---|
| CARBOMEDICS CARBO-SEALCorcym SRLAortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft | AP-023 | Corcym SRL | Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLCAortic open-surgery heart valve bioprosthesis | 2700 | Edwards Lifesciences LLC | Aortic open-surgery heart valve bioprosthesis |
| Contegra®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | 200SH12 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| Contegra®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | 200SH16 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| Contegra®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | 200SH20 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| Contegra®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | 200H14 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| Contegra®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | 200H22 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| EdwardsEdwards Lifesciences LLCCardiac implantation catheter platform base, single-use | 10000UP | Edwards Lifesciences LLC | Cardiac implantation catheter platform base, single-use |
| Edwards Certitude Delivery SystemEdwards Lifesciences LLCAortic transcatheter heart valve bioprosthesis, stent-like framework | 9630TA23 | Edwards Lifesciences LLC | Aortic transcatheter heart valve bioprosthesis, stent-like framework |
| Edwards EVOQUE Loading SystemEdwards Lifesciences LLCVascular catheter introduction set, nonimplantable | 9850LSAUS | Edwards Lifesciences LLC | Vascular catheter introduction set, nonimplantable |
| Edwards EVOQUE Loading SystemEdwards Lifesciences LLCVascular catheter introduction set, nonimplantable | 9850LSB | Edwards Lifesciences LLC | Vascular catheter introduction set, nonimplantable |
| EDWARDS INTUITY ELITE AORTIC VALVEEdwards Lifesciences LLCAortic open-surgery heart valve bioprosthesis | 8300AB | Edwards Lifesciences LLC | Aortic open-surgery heart valve bioprosthesis |
| Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCPulmonary transcatheter heart valve bioprosthesis | 9631PL23A | Edwards Lifesciences LLC | Pulmonary transcatheter heart valve bioprosthesis |
| Evolut™ FXMedtronic Corevalve LLCAortic transcatheter heart valve bioprosthesis, stent-like framework | D-EVOLUTFX-2329 | Medtronic Corevalve LLC | Aortic transcatheter heart valve bioprosthesis, stent-like framework |
| EVOQUEEdwards Lifesciences LLCVascular catheter introduction set, nonimplantable | 9850DKUS | Edwards Lifesciences LLC | Vascular catheter introduction set, nonimplantable |
| HANCOCK®Medtronic, Inc.Pulmonary open-surgery heart valve bioprosthesis | HC15022 | Medtronic, Inc. | Pulmonary open-surgery heart valve bioprosthesis |
| INSPIRIS RESILIA AORTIC VALVEEdwards Lifesciences LLCAortic open-surgery heart valve bioprosthesis | 11500A | Edwards Lifesciences LLC | Aortic open-surgery heart valve bioprosthesis |
| On-X Aortic Heart Valve with Standard Sewing RingOn-X Life Technologies, Inc.Aortic bi-leaflet mechanical heart valve prosthesis | ONXA-23 | On-X Life Technologies, Inc. | Aortic bi-leaflet mechanical heart valve prosthesis |
| On-X Ascending Aortic ProsthesisOn-X Life Technologies, Inc.Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft | ONXAAP-27/29 | On-X Life Technologies, Inc. | Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft |
| PASCALEdwards Lifesciences LLCCardiac implantation catheter platform, single-use | 10000T | Edwards Lifesciences LLC | Cardiac implantation catheter platform, single-use |
| SynCardia Companion Hospital CartSyncardia Systems, LLCVentricular prosthesis system, pneumatically-powered | 397003-001 | Syncardia Systems, LLC | Ventricular prosthesis system, pneumatically-powered |
| SynCardia Freedom® Car ChargerSyncardia Systems, LLCVentricular prosthesis system, pneumatically-powered | 295053-001 | Syncardia Systems, LLC | Ventricular prosthesis system, pneumatically-powered |
| SynCardia Freedom® Standby Kit Shipping ContainerSyncardia Systems, LLCVentricular prosthesis system, pneumatically-powered | 595510-001 | Syncardia Systems, LLC | Ventricular prosthesis system, pneumatically-powered |
| Tendyne™St. Jude Medical, Inc.Mitral transcatheter heart valve bioprosthesis | TENDV-LP-33S | St. Jude Medical, Inc. | Mitral transcatheter heart valve bioprosthesis |
| Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.Aortic transcatheter heart valve bioprosthesis, stent-like framework | TRILOGY-THV-L | Jenavalve Technology, Inc. | Aortic transcatheter heart valve bioprosthesis, stent-like framework |