K110627 is an FDA 510(k) clearance for the NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Marvao Medical Devices, Ltd. (Northborough, US). The FDA issued a Cleared decision on August 12, 2011, 161 days after receiving the submission on March 4, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K110627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2011 |
| Decision Date | August 12, 2011 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |