K024239 is an FDA 510(k) clearance for the CHEMO DISPENSING PIN, MODEL 12495. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 13, 2003, 21 days after receiving the submission on December 23, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K024239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2002 |
| Decision Date | January 13, 2003 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |