Data / Medical devices / United States / Chinook Medical Gear, Inc.
Chinook Medical Gear, Inc.: FDA-registered device maker in Tulsa, OK, United States, 1 510(k) clearance
Chinook Medical Gear, Inc. is registered with the FDA (registration 3004468406) in Tulsa, OK, United States. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004468406
- Address
- 12505 E 55th Street Unit B, Tulsa, OK, United States, 74146
- Owner or operator
- Altitude Technologies, Inc DBA Chinook Medical Gear (10030316)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 15, 2013
- Registered through
- 2026
- Brand names listed
- FS EZ IO Kit Manual 6PK, Pressure Injury Prevention Kit
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 9, 2018 | K180395 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
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Updated November 9, 2018. 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.