510(k) K181208 ยท PND Midline Catheter
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
| Applicant | Vygon USA, Lansdale PA, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | May 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2019 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 4Fr x 20cm Single Lumen CT
Midline Basic Tray, Product Code: VYML4S1001 Terminated |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.