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 (60cm).
| Device ID | K171571 |
| 510k Number | K171571 |
| Device Name: | NexSite HD, Hemodialysis Step Tip Catheter (60cm) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Marvao Medical Devices, Ltd. GMIT Innovation In Business Centre, Dublin Road Galway, IE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2017-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391525640365 | K171571 | 000 |