GIE Medical
United Statesfrom the FDA registration address FDA FEI 3031230150
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What GIE Medical makes
GIE Medical manufactures the Wireguided Balloon Dilation Catheter, a Class II device used for vascular dilation procedures.
This product is regulated under the FDA’s 510(k) pathway and is listed in the U.S. regulatory database. The company is based in the United States.
Catalogue
BARE Wireguided Balloon Dilation Catheter (1235) Ref K253987
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3031230150
- Address
- 7601 Northland Dr N Ste 170, Brooklyn Park, MN, 55428
Frequently asked questions
How many devices does GIE Medical have in the registry?
The registry currently lists 1 device for GIE Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list GIE Medical's devices?
Among its 1 most recently registered device, GIE Medical has devices listed in FDA 510(k) (1 device).
What risk classes do GIE Medical's devices fall under?
Among its 1 most recently registered device, the classes recorded for GIE Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from GIE Medical in the registry?
The most recently registered devices listed for GIE Medical include BARE Wireguided Balloon Dilation Catheter (1235).