Data / Medical devices / United States / Mercator Medsystems, Inc.
Mercator Medsystems, Inc.: FDA-registered device maker in San Leandro, CA, United States, 2 510(k) clearances
Mercator Medsystems, Inc. is registered with the FDA (registration 3004142795) in San Leandro, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004142795
- Address
- 520 McCormick Street, San Leandro, CA, United States, 94577
- Owner or operator
- MERCATOR MEDSYSTEMS (9058124)
- Roles
- Manufacturer
- First device listed
- December 18, 2013
- Registered through
- 2026
- Brand names listed
- Blowfish Transbronchial Microinfusion Catheter, Bullfrog Micro-Infusion Device, Leapfrog Micro-Infusion Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 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 |
|---|---|---|---|---|---|---|
| August 2, 2021 | K210339 | Bullfrog Micro-Infusion Device | KRA | Substantially Equivalent | Mercator Medsystems, Inc. | accessdata.fda.gov |
| July 2, 2013 | K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | EOQ | Substantially Equivalent | Mercator Medsystems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 2, 2021. 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.