K001233 is an FDA 510(k) clearance for the ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on December 13, 2000, 240 days after receiving the submission on April 17, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K001233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2000 |
| Decision Date | December 13, 2000 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |