Data / Medical devices / United States / Vizaramed, Inc.
Vizaramed, Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Vizaramed, Inc. is registered with the FDA (registration 3027366703) in San Jose, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027366703
- Address
- 1914 O'Toole Way, San Jose, CA, United States, 95131
- Owner or operator
- VIzaramed, Inc. (10088098)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 24, 2023
- Registered through
- 2026
- Brand names listed
- Multiflex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Catheter | DYB | 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 |
|---|---|---|---|---|---|---|
| March 26, 2026 | K260626 | Multiflex Steerable Sheath 17.5F | DYB | Substantially Equivalent | Vizaramed, Inc. | accessdata.fda.gov |
| November 14, 2022 | K221655 | Multiflex Steerable Sheath | DYB | Substantially Equivalent | Vizaramed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 26, 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.