The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for 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 Symmetr.
| Device ID | K173805 |
| 510k Number | K173805 |
| Device Name: | 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 Symmetr |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Marvao Medical Devices, Ltd. GMIT Innovation In Business Centre, Dublin Road Galway, IE H91 Dch9 |
| Contact | Christopher Davey |
| Correspondent | Mary P Legraw Boston Biomedical Associates 100 Crowley Drive Suite 216 Marlborough, MA 01752 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-02-08 |
| Summary: | summary |