510(k) K122854 ยท DYB Introducer, Catheter
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
| Applicant | Arrow International (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Jan 4, 2013 |
| Received | Sep 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2017 | Arrow International Inc Arrow Glide Thru Peel-Away Sheath/Dilator Introducer Terminated |
DYB | None listed |
| Nov 4, 2015 | Arrow International Inc ARROW PICC Kit featuring Chlorag+ard Technology
Midline Catheterization Kit
ARROW Advantage5 Pressure Injectable PICC Kit
Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet
ARROW Pressur Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.