Data / Medical devices / United States / AngioSafe
AngioSafe: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
AngioSafe is registered with the FDA (registration 3013757884) 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 22, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013757884
- Address
- 5215 Hellyer Ave Ste 240, San Jose, CA, United States, 95138
- Owner or operator
- AngioSafe (10055439)
- Roles
- Manufacturer
- First device listed
- November 17, 2025
- Registered through
- 2027
- Brand names listed
- Santreva-ATK Endovascular Revascularization Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | 2 | Manufacturer | 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 22, 2025 | K252315 | Santreva-ATK Endovascular Revasculariztion Catheter | PDU | Substantially Equivalent | AngioSafe, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 22, 2025. 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.