K190559 is an FDA 510(k) clearance for the SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 22, 2020, 444 days after receiving the submission on March 5, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K190559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2019 |
| Decision Date | May 22, 2020 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |