K041042 is an FDA 510(k) clearance for the SPLIT SEPTUM INJECTION SITES. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on July 16, 2004, 85 days after receiving the submission on April 22, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K041042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2004 |
| Decision Date | July 16, 2004 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |