K042410 is an FDA 510(k) clearance for the BAXJECT II. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Baxter Healthcare Corp (Westlake Village, US). The FDA issued a Cleared decision on October 8, 2004, 31 days after receiving the submission on September 7, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K042410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2004 |
| Decision Date | October 08, 2004 |
| Days to Decision | 31 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |