K041845 is an FDA 510(k) clearance for the NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on August 24, 2004, 47 days after receiving the submission on July 8, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K041845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2004 |
| Decision Date | August 24, 2004 |
| Days to Decision | 47 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 |