Data / Medical devices / United States / Vantis Vascular, Inc.
Vantis Vascular, Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
Vantis Vascular, Inc. is registered with the FDA (registration 3032277090) in San Jose, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 30, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3032277090
- Address
- 2570 N 1st St Ste 200, San Jose, CA, United States, 95131
- Owner or operator
- Vantis Vascular, Inc. (10091990)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 22, 2024
- Registered through
- 2027
- Brand names listed
- CrossFAST Integrated Microcatheter Advanced Delivery System, CrossFAST Integrated Microcatheter Guide Extension System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 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 |
|---|---|---|---|---|---|---|
| September 30, 2024 | K242276 | CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | DQY | Substantially Equivalent | Vantis Vascular, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 30, 2024. 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.