Data / Medical devices / United States / Portal Access Inc
Portal Access Inc: FDA-registered device maker in Miami Beach, FL, United States, 1 510(k) clearance
Portal Access Inc is registered with the FDA (registration 3047514279) in Miami Beach, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3047514279
- Address
- 4201 Collins Ave Apt 601, Miami Beach, FL, United States, 33140
- Owner or operator
- Portal Access Inc (10096113)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 27, 2026
- Registered through
- 2026
- Brand names listed
- FLEXI-PORT, Tunneler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 17, 2026 | K260916 | FLEXI-PORT Power Injectable Implantable Port | LJT | Substantially Equivalent | Portal Access, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Port & Catheter, Implanted, Subcutaneous, Intravascular
- All makers of Instrument, Manual, Surgical, General Use
Updated June 17, 2026. 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.