Data / Medical devices / United States / Agile Devices, Inc.
Agile Devices, Inc.: FDA-registered device maker in Newton Centre, MA, United States, 1 510(k) clearance
Agile Devices, Inc. is registered with the FDA (registration 3023167283) in Newton Centre, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023167283
- Address
- 1087 Beacon Street Suite 302, Newton Centre, MA, United States, 02459
- Owner or operator
- Agile Devices, Inc. (10085522)
- Roles
- Manufacturer
- First device listed
- June 28, 2022
- Registered through
- 2026
- Brand names listed
- Angler Steerable, Deflectable Microcatheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | 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 |
|---|---|---|---|---|---|---|
| January 7, 2022 | K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | KRA | Substantially Equivalent | Agile Devices, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2022. 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.