The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Smartport+ Implantable Ports, Smartport Plastic Implantable Ports.
| Device ID | K190559 |
| 510k Number | K190559 |
| Device Name: | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Vidyalakshmi Jayaraman |
| Correspondent | Vidyalakshmi Jayaraman AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2020-05-22 |