K024190 is an FDA 510(k) clearance for the FENESTRATED INFUSION CATHETER. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on March 17, 2003, 88 days after receiving the submission on December 19, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K024190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2002 |
| Decision Date | March 17, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |