Avalon Laboratories, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Avalon Laboratories, LLC makes
Avalon Laboratories, LLC manufactures vascular access kits and multi-port venous catheters, including femoral catheters in sizes ranging from 20FR to 28FR, as well as bi-caval dual lumen catheters in sizes from 13FR to 31FR. These products are designed for central venous access procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The products are intended for use in the United States.
Catalogue
Avalon Elite Vascular Access Kit Ref K081940
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Avalon Laboratories, LLC have in the registry?
The registry currently lists 3 devices for Avalon Laboratories, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Avalon Laboratories, LLC's devices?
Among its 3 most recently registered devices, Avalon Laboratories, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Avalon Laboratories, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Avalon Laboratories, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Avalon Laboratories, LLC in the registry?
The most recently registered devices listed for Avalon Laboratories, LLC include AVALON ELITE VASCULAR ACCESS KIT, AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR and AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR.