K953825 is an FDA 510(k) clearance for the ANGIOFLUSH II FLUID MANAGEMENT SYSTEM. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on February 26, 1996, 195 days after receiving the submission on August 15, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K953825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1995 |
| Decision Date | February 26, 1996 |
| Days to Decision | 195 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 |