K092318 is an FDA 510(k) clearance for the BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on October 30, 2009, 87 days after receiving the submission on August 4, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K092318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2009 |
| Decision Date | October 30, 2009 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| 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 |