510(k) K192291 ยท PTD Subcutaneous Implanted Apheresis Port
TidalPort-AP Implantable Apheresis Vascular Access Port
| Applicant | Norfolk Medical Products, Inc., Skokie IL, US |
| Decision | Substantially Equivalent, Aug 20, 2020 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192291
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.