Marvao Medical Devices, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Marvao Medical Devices, Ltd.” (first 2011, latest 2022), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 119 days. Since 2017 the median was 90 days, against 108 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 255 |
| 2014 | 2 | 154 |
| 2015 | 1 | 105 |
| 2016 | 1 | 119 |
| 2017 | 1 | 184 |
| 2018 | 1 | 55 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Marvao Medical Devices, Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 7 | 7 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
Most recent Marvao Medical Devices, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220632 | Boss Crossing Support Catheter | DQY | 2022-06-02 | 90 |
| 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 | 2018-02-08 | 55 |
| K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | MSD | 2017-11-30 | 184 |
| K161026 | NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) | MSD | 2016-08-09 | 119 |
| 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 | 2015-03-31 | 105 |
| K140492 | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | MSD | 2014-11-13 | 259 |
| K133796 | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), | MSD | 2014-01-31 | 49 |
| K121933 | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) | MSD | 2013-03-14 | 255 |
| K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | LJS | 2011-08-12 | 161 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-02-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Marvao Medical Devices, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Marvao Medical Devices, Ltd.” (first 2011, latest 2022), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Marvao Medical Devices, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marvao Medical Devices, Ltd. is 119 days. Since 2017: 90 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Marvao Medical Devices, Ltd.?
The most frequent FDA product codes under this applicant name are MSD (Catheter, Hemodialysis, Implanted, 7); DQY (Catheter, Percutaneous, 1); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 1).
Next steps
- See all 9 Marvao Medical Devices, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MSD, Marvao Medical Devices, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.