Marvao Medical Devices Ltd.
Galway Galway, IE
MARVAO MEDICAL DEVICES LTD. appears in FDA device records in Galway Galway, IE. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Marvao Medical Devices Ltd. between 2011 and 2022. The busiest year on record is 2014, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220632 | Boss Crossing Support Catheter | DQY | Substantially Equivalent | |
| 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 | |
| K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | MSD | Unknown | |
| K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) | MSD | Unknown | |
| K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) | MSD | Unknown | |
| K140492 | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | MSD | Substantially Equivalent | |
| K133796 | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), | MSD | Unknown | |
| K121933 | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) | MSD | Substantially Equivalent | |
| K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | LJS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008110587 | 3008110587 | MARVAO MEDICAL DEVICES LTD. | Unit 1 Galway Business PArk, Galway Galway(County) Galway IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1699-2021 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain