Guidewire Technologies, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1221806
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
What Guidewire Technologies, Inc. makes
Guidewire Technologies, Inc. manufactures guidewires, including standard guidewires, movable core guidewires, and Teflon-coated guidewires. These devices are designed for use in interventional cardiology procedures to facilitate catheter navigation within blood vessels.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance pathway. Guidewire Technologies, Inc. is based in the United States.
Catalogue
Guidewire Ref K890959
Regimes: 510(k) Registry: 510(k)Movable Core Guidewire Ref K902152
Regimes: 510(k) Registry: 510(k)Teflon Coated Guidewire Ref K902153
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1221806
- Address
- 26 KEEWAYDIN DR., SALEM, NH, 03079
Frequently asked questions
How many devices does GUIDEWIRE TECHNOLOGIES, INC. have in the registry?
The registry currently lists 3 devices for GUIDEWIRE TECHNOLOGIES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GUIDEWIRE TECHNOLOGIES, INC.'s devices?
Among its 3 most recently registered devices, GUIDEWIRE TECHNOLOGIES, INC. has devices listed in FDA 510(k) (3 devices).
What risk classes do GUIDEWIRE TECHNOLOGIES, INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for GUIDEWIRE TECHNOLOGIES, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from GUIDEWIRE TECHNOLOGIES, INC. in the registry?
The most recently registered devices listed for GUIDEWIRE TECHNOLOGIES, INC. include GUIDEWIRE, MOVABLE CORE GUIDEWIRE and TEFLON COATED GUIDEWIRE.