510(k) K161313 ยท PND Midline Catheter
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Aug 24, 2016 |
| Received | May 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2022 | ARROW INTERNATIONAL Inc. ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood Terminated |
PND | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance Midline
Product Code: PR 41541 BAS Terminated |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.