510(k) K820883 ยท DYG Catheter, Flow Directed
SEPTISLEEVE
| Applicant | Argon Medical Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 29, 1982 |
| Received | Mar 30, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.