Lake Region Mfg., Inc.
United StatesFDA applicant, unverified
- Devices
- 42
What Lake Region Mfg., Inc. makes
Lake Region Mfg., Inc. manufactures cardiovascular spring guides, including steerable and open-ended guidewires, as well as custom modifications like wire and core assemblies. Their portfolio also includes torque handle devices for guidewires, fasculated nails, and variable stiffness guidewires such as the Lake Region Variable Stiffness Guidewire (VSGW) and Amplatzer Moveable Core Guidewire. The company produces guidewires on an OEM basis for distribution to manufacturers, kit assemblers, and distributors, covering coronary, peripheral, and renal applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) registry. Lake Region Mfg., Inc. is based in the United States.
Catalogue
Search and filter all 42 devicesFrequently asked questions
How many devices does Lake Region Mfg., Inc. have in the registry?
The registry currently lists 42 devices for Lake Region Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lake Region Mfg., Inc.'s devices?
Among its 42 most recently registered devices, Lake Region Mfg., Inc. has devices listed in FDA 510(k) (42 devices).
What risk classes do Lake Region Mfg., Inc.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Lake Region Mfg., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lake Region Mfg., Inc. in the registry?
The most recently registered devices listed for Lake Region Mfg., Inc. include CARDIOVASCULAR SPRING GUIDES, LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS, KIT ASSEMBLERS, AND DISTRIBUTORS., LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) and FASICULATED NAIL.