Data / Medical devices / United States / F Care Systems Usa
F Care Systems Usa: FDA-registered device maker in Miami, FL, United States, 4 510(k) clearances
F Care Systems Usa is registered with the FDA (registration 3008816935) in Miami, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008816935
- FEI number
- 3009438986
- Address
- 755 Ne 164TH Terrace, Miami, FL, United States, 33162
- Owner or operator
- F CARE SYSTEMS USA (10035152)
- Roles
- Repackager or relabeler
- First device listed
- March 26, 2013
- Registered through
- 2026
- Brand names listed
- EVRF, HPR 45i, KAVS, MED RF 4000, RAFAELO CATHETER HPR, SUPER SETON, THERMAVEIN, VIRIDEX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Pediatric, General & Plastic Surgery | GBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical Coagulation For Aesthetic | ONQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | 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 20, 2023 | K220725 | HPR45i | GEI | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| December 17, 2021 | K210077 | MED RF 4000 | ONQ | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| March 7, 2013 | K130283 | EVRF SYSTEM | ONQ | Substantially Equivalent | F Care Systems NV | accessdata.fda.gov |
| March 20, 2006 | K052844 | KAVS - CATHETER, MODELS 1107100 & 1107060 | MJN | Substantially Equivalent | Richter & Rothe AG | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical Coagulation For Aesthetic
- All makers of Catheter, Pediatric, General & Plastic Surgery
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Catheter, Intravascular Occluding, Temporary
Updated March 20, 2023. 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.