Tractus Vascular, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Tractus Vascular, LLC makes
Tractus Vascular, LLC manufactures catheters designed for vascular procedures, including the Tunnel Crossing Catheter, Tractus Crossing Support Catheter, and Crossing Support Catheter. These devices are intended for use in crossing complex vascular lesions or occlusions, aiding in interventional radiology and cardiology procedures.
The company’s products fall under FDA Class II devices and are authorised via the 510(k) pathway. The portfolio is regulated under US medical device laws, with listings maintained in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Tunnel Crossing Catheter Ref K221163
Regimes: 510(k) Registry: 510(k)Tractus Crossing Support Catheter Ref K180889
Regimes: 510(k) Registry: 510(k)Crossing Support Catheter Ref K183305
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tractus Vascular, LLC have in the registry?
The registry currently lists 3 devices for Tractus Vascular, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tractus Vascular, LLC's devices?
Among its 3 most recently registered devices, Tractus Vascular, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Tractus Vascular, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Tractus Vascular, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tractus Vascular, LLC in the registry?
The most recently registered devices listed for Tractus Vascular, LLC include Tunnel Crossing Catheter, Tractus Crossing Support Catheter and Crossing Support Catheter.