510(k) K160785 ยท DQX Wire, Guide, Catheter
Worker Guidewire
| Applicant | Argon Medical Devices, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Dec 8, 2016 |
| Received | Mar 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO Terminated |
DQX | None listed |
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.