K024363 is an FDA 510(k) clearance for the NEXUS INJECTION SITE (NIS), MODEL NIS-1. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Nexus Medical, LLC (Raleigh, US). The FDA issued a Cleared decision on February 19, 2003, 50 days after receiving the submission on December 31, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K024363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2002 |
| Decision Date | February 19, 2003 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |