The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite Hd Hemodialysis Catheter For Long Term Use (28cm) Nexsite Hd Hemodialysis Catheter For Long Term Use (24cm).
| Device ID | K121933 |
| 510k Number | K121933 |
| Device Name: | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northborough, MA 01532 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber 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 | 2012-07-02 |
| Decision Date | 2013-03-14 |
| Summary: | summary |