Data / Medical devices / United States / Corcym Inc.
Corcym Inc.: FDA-registered device maker in Englewood, CO, United States, 2 510(k) clearances
Corcym Inc. is registered with the FDA (registration 3019892983) in Englewood, CO, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 10, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019892983
- Address
- 9800 Mount Pyramid Court, Suite #400, Englewood, CO, United States, 80112
- Owner or operator
- Corcym S.r.l. (9083203)
- Roles
- Manufacturer
- First device listed
- November 30, 2023
- Registered through
- 2026
- Brand names listed
- HAART 200 Aortic Annuloplasty Device and accessories, HAART 300 Aortic Annuloplasty Device and accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Annuloplasty Ring | PST | 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 10, 2017 | K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | PST | Substantially Equivalent | Biostable Science & Engineering, Inc. | accessdata.fda.gov |
| March 21, 2017 | K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm | PST | Substantially Equivalent | Biostable Science & Engineering, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 10, 2017. 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.