K924064 is an FDA 510(k) clearance for the INTERLINK UNIVERSAL VIAL ADAPTER. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on April 21, 1993, 252 days after receiving the submission on August 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K924064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1992 |
| Decision Date | April 21, 1993 |
| Days to Decision | 252 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 |