The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for 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 .
| Device ID | K143567 |
| 510k Number | K143567 |
| Device Name: | 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 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MARVAO MEDICAL DEVICES, LTD. GMIT INNOVATION IN BUSINESS CENTRE, DUBLIN RD Galway, IE |
| Contact | Christopher Davey |
| Correspondent | Christine Nichols BOSTON BIOMEDICAL ASSOCIATES 100 CROWLEY DRIVE, SUITE 216 Marlboro, 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 | 2014-12-16 |
| Decision Date | 2015-03-31 |
| Summary: | summary |