Data / Medical devices / United States / Guidewire Technologies, Inc.
Guidewire Technologies, Inc.: FDA-registered device maker in Salem, NH, United States, 2 510(k) clearances
Guidewire Technologies, Inc. is registered with the FDA (registration 1221806) in Salem, NH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 31, 1990. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221806
- Address
- 26 Keewaydin DR., Salem, NH, United States, 03079
- Owner or operator
- GUIDEWIRE TECHNOLOGIES, INC. (1221806)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 6, 1992
- Registered through
- 2026
- Brand names listed
- GUIDEWIRE, PTFE Coated Guidewire, Uncoated Guidewire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 1990 | K902153 | TEFLON COATED GUIDEWIRE | DQX | Substantially Equivalent | Guidewire Technologies, Inc. | accessdata.fda.gov |
| September 12, 1989 | K890959 | GUIDEWIRE | DQX | Substantially Equivalent | Guidewire Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 31, 1990. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.