The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angioflush Ii Fluid Management System.
| Device ID | K953825 |
| 510k Number | K953825 |
| Device Name: | ANGIOFLUSH II FLUID MANAGEMENT SYSTEM |
| Classification | Set, Administration, Intravascular |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1996-02-26 |