Data / Medical devices / United States / Helios Cardio Inc.
Helios Cardio Inc.: FDA-registered device maker in Natick, MA, United States, 1 510(k) clearance
Helios Cardio Inc. is registered with the FDA (registration 3020856782) in Natick, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3020856782
- Address
- 33 Strathmore Rd, Natick, MA, United States, 01760
- Owner or operator
- Helios Cardio Inc. (10083222)
- Roles
- Specification developer
- First device listed
- December 22, 2021
- Registered through
- 2026
- Brand names listed
- CardiaMend
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | 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 |
|---|---|---|---|---|---|---|
| December 21, 2021 | K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | PSQ | Substantially Equivalent | Helios Cardio, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2021. 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.