MARVAO MEDICAL DEVICES LTD.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1699-2021 | Class II | NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use | February 11, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220632 | Boss Crossing Support Catheter | June 2, 2022 |
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Sym | February 8, 2018 |
| K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | November 30, 2017 |
| K161026 | NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 | August 9, 2016 |
| K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split T | March 31, 2015 |
| K140492 | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | November 13, 2014 |
| K133796 | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LO | January 31, 2014 |
| K121933 | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG | March 14, 2013 |
| K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | August 12, 2011 |