G V Medical, Inc.
Country not established
- Devices
- 2
What G V Medical, Inc. makes
G V Medical, Inc. manufactures balloon dilatation catheters, including the LASTAC Balloon Dilatation Catheter, and the LASTAC System, which combines catheter and related components for vascular interventions. These devices are designed for percutaneous transluminal angioplasty (PTA) to treat arterial stenosis or occlusions in peripheral and coronary arteries. The portfolio also includes specialized catheters for use in interventional radiology and cardiology procedures.
The company’s devices are regulated under the US Food and Drug Administration (FDA) as Class II and Class III medical devices, requiring premarket approval (PMA) or 510(k) clearance. Products are listed in the FDA’s 510(k) and PMA registries, adhering to US regulatory standards for safety and performance. The manufacturer operates from the United States.
Catalogue
- 510(k) 510(k)
Lastac System Ref P870071
PMA PMA
Frequently asked questions
How many devices does G V Medical, Inc. have in the registry?
The registry currently lists 2 devices for G V Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list G V Medical, Inc.'s devices?
Among its 2 most recently registered devices, G V Medical, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do G V Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for G V Medical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from G V Medical, Inc. in the registry?
The most recently registered devices listed for G V Medical, Inc. include GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE and LASTAC SYSTEM.