Data / Medical devices / United States / A2 Medical Systems, LLC
A2 Medical Systems, LLC: FDA-registered device maker in Kalamazoo, MI, United States, 2 510(k) clearances
A2 Medical Systems, LLC is registered with the FDA (registration 3020965506) in Kalamazoo, MI, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020965506
- Address
- 6387 Technology Avenue Suite F, Kalamazoo, MI, United States, 49009
- Owner or operator
- A2 MEDICAL SYSTEMS, LLC (10083365)
- Roles
- Specification developer
- First device listed
- November 15, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Specification developer | accessdata.fda.gov |
| Clip, Implantable | FZP | 2 | Specification developer | accessdata.fda.gov |
| Clip, Vascular | DSS | 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 |
|---|---|---|---|---|---|---|
| September 19, 2023 | K230966 | angiOCCLUDE Ligating Clips | FZP | Substantially Equivalent | A2 Medical Systems, LLC | accessdata.fda.gov |
| March 2, 2022 | K220006 | angioLOCK Polymer Ligating Clip | FZP | Substantially Equivalent | A2 Medical Systems, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 19, 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.