The following data is part of a premarket notification filed by Angiodynamics, Div. E-z-em, Inc. with the FDA for Pulse Spray Infusion System.
| Device ID | K961763 |
| 510k Number | K961763 |
| Device Name: | PULSE SPRAY INFUSION SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | ANGIODYNAMICS, DIV. E-Z-EM, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst ANGIODYNAMICS, DIV. E-Z-EM, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-07 |
| Decision Date | 1996-07-17 |