Hotspur Technologies
Country not established
- Devices
- 7
What Hotspur Technologies makes
Hotspur Technologies manufactures percutaneous transluminal angioplasty (PTA) balloon catheters, including single-use and dual-lumen designs for vascular dilation, as well as embolectomy catheters for clot removal in peripheral and coronary arteries. Their product line includes fixed-size PTA balloons (5 mm and 6 mm diameters) and balloon catheters with guidewire compatibility for targeted vessel treatment. Additional offerings include balloon dilation catheters for graft and stent placement, designed for use in peripheral vascular interventions.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Pta-Duo Pta Balloon Catheter Ref K101047
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Gpscath Ballon Dilatation Catheter Ref K113769
Regimes: 510(k) Registry: 510(k)Embo Plus Embolectomy Catheter Ref K100840
Regimes: 510(k) Registry: 510(k)Arrow Gpscath Balloon Dilatation Catheter Ref K130397
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hotspur Technologies have in the registry?
The registry currently lists 7 devices for Hotspur Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hotspur Technologies's devices?
Among its 7 most recently registered devices, Hotspur Technologies has devices listed in FDA 510(k) (7 devices).
What risk classes do Hotspur Technologies's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Hotspur Technologies's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hotspur Technologies in the registry?
The most recently registered devices listed for Hotspur Technologies include PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM, PTA-DUO PTA BALLOON CATHETER, Arrow GPSCath Balloon Dialation Catheter (150 cm) and 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm).