Data / Medical devices / Ireland / Marvao Medical Devices Ltd.
Marvao Medical Devices Ltd.: FDA-registered device maker in Galway Galway(County), Ireland, 2 510(k) clearances
Marvao Medical Devices Ltd. is registered with the FDA (registration 3008110587) in Galway Galway(County), Ireland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 2, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008110587
- Address
- Unit 1 Galway Business PArk Dangan, Galway Galway(County), Ireland, Galway
- Owner or operator
- Marvao Medical Devices Ltd. (10039455)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 20, 2018
- Registered through
- 2026
- Brand names listed
- Boss Crossing Support Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Hemodialysis, Implanted | MSD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 2, 2022 | K220632 | Boss Crossing Support Catheter | DQY | Substantially Equivalent | Marvao Medical Devices, Ltd. | accessdata.fda.gov |
| February 8, 2018 | K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) | MSD | Unknown | Marvao Medical Devices, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 11, 2020 | 87827 | Class II | Ongoing | NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use | The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. | accessdata.fda.gov |
Compare with other makers
Updated June 2, 2022. 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.