The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite Hd (55cm), Hemodialysis Catheter For Long Term Use.
| Device ID | K140492 |
| 510k Number | K140492 |
| Device Name: | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET, SUITE 7 Northborough, MA 01532 |
| Contact | Christine Nichols |
| Correspondent | Christine Nichols MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET, SUITE 7 Northborough, MA 01532 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-11-13 |
| Summary: | summary |