K053129 is an FDA 510(k) clearance for the NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5. 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 December 8, 2005, 30 days after receiving the submission on November 8, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K053129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2005 |
| Decision Date | December 08, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |