Vascumetrix, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Vascumetrix, LLC makes
Vascumetrix, LLC manufactures vascular dilators, including the GELBFISH FLEX VASCULAR DILATOR and the GELBISH VASCULAR DILATOR, as well as modifications to existing dilator designs. These devices are intended for use in expanding or maintaining vascular pathways, aiding procedures such as angioplasty or stent placement.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Gelbfish Flex Vascular Dilator Ref K030260
Regimes: 510(k) Registry: 510(k)Gelbish Vascular Dilator Ref K012256
Regimes: 510(k) Registry: 510(k)Modification To Gelbfish Vascular Dilators Ref K023507
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Vascumetrix, LLC have in the registry?
The registry currently lists 3 devices for Vascumetrix, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vascumetrix, LLC's devices?
Among its 3 most recently registered devices, Vascumetrix, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Vascumetrix, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Vascumetrix, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vascumetrix, LLC in the registry?
The most recently registered devices listed for Vascumetrix, LLC include GELBFISH FLEX VASCULAR DILATOR, GELBISH VASCULAR DILATOR and MODIFICATION TO GELBFISH VASCULAR DILATORS.