The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Smartport Ct Mp Port Access System And Lifeguard Ct Safety Infusion Set.
| Device ID | K072375 |
| 510k Number | K072375 |
| Device Name: | SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET |
| 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 | 2007-08-23 |
| Decision Date | 2007-12-13 |
| Summary: | summary |