Data / Medical devices / United States / Cortex, Inc.
Cortex, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 4 510(k) clearances
Cortex, Inc. is registered with the FDA (registration 3013627970) in Santa Clara, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013627970
- Address
- 5455 Great America Parkway Ste 301, Santa Clara, CA, United States, 95054
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 27, 1992
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Specification developer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | MTD | Substantially Equivalent | Cortex, Inc. | accessdata.fda.gov |
| May 28, 2025 | K251344 | OptiMap System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 8, 2023 | K230008 | Ablamap® System | DQK | Substantially Equivalent | Ablacon, Inc. | accessdata.fda.gov |
| March 17, 2023 | K223666 | Ablacath Mapping Catheter | MTD | Substantially Equivalent | Ablacon, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrode, Electrocardiograph
- All makers of Cable, Electrode
- All makers of Catheter, Intracardiac Mapping, High-Density Array
Updated March 13, 2026. 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.