Data / Medical devices / United States / Corvitex Corporation
Corvitex Corporation: FDA-registered device maker in Raleigh, NC, United States, 1 510(k) clearance
Corvitex Corporation is registered with the FDA (registration 3039062605) in Raleigh, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039062605
- Address
- 4928 Windy Hill Dr Ste B, Raleigh, NC, United States, 27609
- Owner or operator
- Corvitex Corporation (10092281)
- Roles
- Complaint file establishment
- First device listed
- July 15, 2025
- Registered through
- 2026
- Brand names listed
- Primum Guiding Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 29, 2025 | K250972 | Primum Hydrophilic Guiding Catheter | DQY | Substantially Equivalent | Pendracare | accessdata.fda.gov |
Compare with other makers
Updated June 29, 2025. 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.