510(k) K213638 ยท DYB Introducer, Catheter
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
| Applicant | Argon Medical Devices, Athens TX, US |
| Decision | Substantially Equivalent, Dec 10, 2021 |
| Received | Nov 18, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213638
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.