Data / Medical devices / United States / Catheter Precision, Incorporated
Catheter Precision, Incorporated: FDA-registered device maker in Fort Mill, SC, United States, 1 510(k) clearance
Catheter Precision, Incorporated is registered with the FDA (registration 3010728615) in Fort Mill, SC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010728615
- Address
- 1670 Highway 160 West Suite 205, Fort Mill, SC, United States, 29708
- Owner or operator
- Catheter Precision (10031997)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 14, 2023
- Registered through
- 2026
- Brand names listed
- LockeT, VIVO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 14, 2020 | K200313 | VIVO | DQK | Substantially Equivalent | Catheter Precision, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 14, 2020. 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.