NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 Cm, 28 Cm, 32 Cm, 36 Cm, 40 Cm, 55 Cm)
Catheter, Hemodialysis, Implanted
MARVAO MEDICAL DEVICES, LTD.
The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite™ Hd Hemodialysis Step Tip Catheter For Long Term Use (24 Cm, 28 Cm, 32 Cm, 36 Cm, 40 Cm, 55 Cm).
Pre-market Notification Details
| Device ID | K161026 |
| 510k Number | K161026 |
| Device Name: | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 Cm, 28 Cm, 32 Cm, 36 Cm, 40 Cm, 55 Cm) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MARVAO MEDICAL DEVICES, LTD. GMIT INNOVATION IN BUSINESS CENTRE, DUBLIN RD Galway, IE H91 Dch9 |
| Contact | Christopher Davey |
| Correspondent | Joseph Depaolo 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 | 2016-04-12 |
| Decision Date | 2016-08-09 |
| Summary: | summary |
Trademark Results [NexSite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXSITE 85210558 4126490 Live/Registered |
Marvao Medical Devices Ltd 2011-01-05 |
 NEXSITE 78113251 2761700 Dead/Cancelled |
John W. McKanna 2002-03-07 |
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