Data / Medical devices / United States / Provisio Medical Inc.
Provisio Medical Inc.: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Provisio Medical Inc. is registered with the FDA (registration 3016171942) in San Diego, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016171942
- Address
- 10815 Rancho Bernardo Rd Suite 110, San Diego, CA, United States, 92127
- Owner or operator
- Provisio Medical Inc. (10090661)
- Roles
- Manufacturer
- First device listed
- April 24, 2024
- Registered through
- 2026
- Brand names listed
- Provisio SLT IVUS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| April 23, 2024 | K233948 | Provisio SLT IVUS System | OBJ | Substantially Equivalent | Provisio Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated April 23, 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.