K003730 is an FDA 510(k) clearance for the CHEMO-AIDE DISPENSING PIN. 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 December 20, 2000, 16 days after receiving the submission on December 4, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K003730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2000 |
| Decision Date | December 20, 2000 |
| Days to Decision | 16 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 |