The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Angiodynamics Angiofill Fluid Management System.
| Device ID | K914026 |
| 510k Number | K914026 |
| Device Name: | ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM |
| Classification | Set, Administration, Intravascular |
| Applicant | E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1992-01-09 |