K242660 is an FDA 510(k) clearance for the Curlin 8000 Ambulatory Infusion System. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Zevex, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 3, 2024, 29 days after receiving the submission on September 4, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2024 |
| Decision Date | October 03, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |