Data / Medical devices / United States / Innova Vascular, Inc.
Innova Vascular, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Innova Vascular, Inc. is registered with the FDA (registration 3020256033) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020256033
- Address
- 15375 Barranca Parkway, B-101, Irvine, CA, United States, 92618
- Owner or operator
- Innova Vascular, Inc. (10088280)
- Roles
- Manufacturer
- First device listed
- June 23, 2023
- Registered through
- 2026
- Brand names listed
- Laguna Clot Retriever System, Malibu Aspiration Catheter System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 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 |
|---|---|---|---|---|---|---|
| June 1, 2023 | K223929 | Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) | QEW | Substantially Equivalent | Innova Vascular, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Catheter, Continuous Flush
Updated June 1, 2023. 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.