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 (32cm), Nexsite Hd, Hemodialysis Catheter For Long Term Use (36cm),.
| Device ID | K133796 |
| 510k Number | K133796 |
| Device Name: | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northborough, MA 01532 |
| Contact | Christine Nichols, Rac |
| Correspondent | Christine Nichols, Rac MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northborough, MA 01532 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-01-31 |
| Summary: | summary |