Medtronic Heart Valves
Country not established
- Devices
- 4
What Medtronic Heart Valves makes
The company manufactures mitral valve repair devices, including annuloplasty rings and bands (e.g., Duran Band, Duran Ring, Duran Ancore Ring), an annuloplasty band (CG Future), a mitral valve repair system (Simplici-T), and a bioprosthetic heart valve (Hancock Modified Orifice). These products are designed for surgical correction of mitral valve dysfunction.
The portfolio includes devices regulated as Class II and Class III under FDA pathways, with submissions recorded in the 510(k) and PMA registries. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cg Future Annuloplasty Band Ref K052860
Regimes: 510(k) Registry: 510(k)Simplici-T Annuloplasty System Ref K052970
Regimes: 510(k) Registry: 510(k)Hancock Modified Orifice Bioprosthesis Ref P790007
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medtronic Heart Valves have in the registry?
The registry currently lists 4 devices for Medtronic Heart Valves. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Heart Valves's devices?
Among its 4 most recently registered devices, Medtronic Heart Valves has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medtronic Heart Valves's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medtronic Heart Valves's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Heart Valves in the registry?
The most recently registered devices listed for Medtronic Heart Valves include DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE, CG FUTURE ANNULOPLASTY BAND, SIMPLICI-T ANNULOPLASTY SYSTEM and HANCOCK MODIFIED ORIFICE BIOPROSTHESIS.