Sulzer Intratherapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Sulzer Intratherapeutics, Inc. makes
The company manufactures self-expanding nitinol stents, including the Protege stent with StarPort delivery technology and its modifications, as well as the IntraStent LD (large diameter) stent and the IntraCoil peripheral stent. These devices are designed for vascular applications, including peripheral and potentially other arterial interventions.
The portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) pathway. The company is based in the United States and its devices are listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Intrastent Ld (Large Diameter) Stent Ref K020528
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Intracoil Self-Expanding Peripheral Stent Ref K021563
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sulzer Intratherapeutics, Inc. have in the registry?
The registry currently lists 8 devices for Sulzer Intratherapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sulzer Intratherapeutics, Inc.'s devices?
Among its 8 most recently registered devices, Sulzer Intratherapeutics, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Sulzer Intratherapeutics, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sulzer Intratherapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sulzer Intratherapeutics, Inc. in the registry?
The most recently registered devices listed for Sulzer Intratherapeutics, Inc. include PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY, MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY, INTRASTENT LD (LARGE DIAMETER) STENT and INTRACOIL SELF-EXPANDING PERIPHERAL STENT.