510(k) K202141 ยท DYB Introducer, Catheter
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
| Applicant | Argon Medical Devices, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Jan 15, 2021 |
| Received | Jul 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202141
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2021 | Argon Medical Devices, Inc Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.