Data / Medical devices / United States / Avacen, Inc.
Avacen, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
Avacen, Inc. is registered with the FDA (registration 3009668937) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009668937
- Address
- 6451 El Camino Real Ste C, Carlsbad, CA, United States, 92009
- Owner or operator
- AVACEN, Inc. (10041019)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 18, 2014
- Registered through
- 2026
- Brand names listed
- AVACEN 100, AVACEN GXL, AVACEN HOME, AVACEN HOME XL, AVACEN PRO, AVACEN PRO+, AVACEN XL, CATHSTA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Intravascular Catheter Securement | KMK | 1 | Specification developer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 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 |
|---|---|---|---|---|---|---|
| August 15, 2014 | K133981 | AVACEN 100 | IRT | Substantially Equivalent | Avacen, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 15, 2014. 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.