Data / Medical devices / United States / Merit Medical Systems, Inc.
Merit Medical Systems, Inc.: FDA-registered device maker in Aliso Viejo, CA, United States, 4 510(k) clearances
Merit Medical Systems, Inc. is registered with the FDA (registration 2032338) in Aliso Viejo, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 12, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032338
- FEI number
- 3003295907
- Address
- 6 Journey, Suite 125, Aliso Viejo, CA, United States, 92656
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Specification developer
- First device listed
- November 28, 2018
- Registered through
- 2027
- Brand names listed
- SAVI Applicator Kit, SAVI Prep Device, SAVI Spacer, SCOUT Console and Accessory Cart, SCOUT MD Console, SCOUT MD Delivery System, SCOUT MD Guides, SCOUT MD Single-use Handpieces and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Specification developer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Specification developer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | 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 |
|---|---|---|---|---|---|---|
| February 12, 2024 | K231468 | SCOUT MD Surgical Guidance System | NEU | Substantially Equivalent | Merit Medical System, Inc. | accessdata.fda.gov |
| August 2, 2018 | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | NEU | Substantially Equivalent | Cianna Medical, Inc. | accessdata.fda.gov |
| July 12, 2010 | K101411 | SAVI PREPARATION DEVICE | JAQ | Substantially Equivalent | Cianna Medical, Inc. | accessdata.fda.gov |
| July 22, 2008 | K081677 | SAVI APPLICATOR KIT | JAQ | Unknown | Cianna Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Radiographic, Implantable
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Updated February 12, 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.