K925401 is an FDA 510(k) clearance for the IV FLUID TRANSFER PIN. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 3, 1993, 128 days after receiving the submission on October 26, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K925401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1992 |
| Decision Date | March 03, 1993 |
| Days to Decision | 128 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 |