K192291 is an FDA 510(k) clearance for the TidalPort-AP Implantable Apheresis Vascular Access Port. This device is classified as a Subcutaneous Implanted Apheresis Port (Class II - Special Controls, product code PTD).
Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on August 20, 2020, 363 days after receiving the submission on August 23, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965. A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis.
| 510(k) Number | K192291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2019 |
| Decision Date | August 20, 2020 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PTD - Subcutaneous Implanted Apheresis Port |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |
| Definition | A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis |