Strait Access Technologies Holdings
South AfricaFDA applicant, unverified
- Devices
- 2
What Strait Access Technologies Holdings makes
Strait Access Technologies Holdings manufactures the SAT CenterFlow Molding Balloon Catheter, a device designed for vascular interventions to facilitate blood flow in coronary arteries through controlled dilation of lesions.
The company’s portfolio is regulated under FDA Class II devices, with the SAT CenterFlow Molding Balloon Catheter listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Strait Access Technologies Holdings have in the registry?
The registry currently lists 2 devices for Strait Access Technologies Holdings. Devices recorded under merged duplicate company entries are counted once.
Which registries list Strait Access Technologies Holdings's devices?
Among its 2 most recently registered devices, Strait Access Technologies Holdings has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Strait Access Technologies Holdings's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Strait Access Technologies Holdings's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Strait Access Technologies Holdings in the registry?
The most recently registered devices listed for Strait Access Technologies Holdings include SAT CenterFlow Molding Balloon Catheter IN20-00313 and SAT CenterFlow Molding Balloon Catheter (IN20-00313).