The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite 9fr Dual Lumen Critical Care Central Venous Catheter.
| Device ID | K110627 |
| 510k Number | K110627 |
| Device Name: | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northboro, MA 01532 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northboro, MA 01532 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-08-12 |
| Summary: | summary |