510(k) K073100 ยท DYB Introducer, Catheter
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Nov 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2011 | Angiodynamics, INC 8F Safe Sheath Introducer, Catalog number: V18;
AngioDynamics, INC.
The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. Terminated |
DYB | None listed |
| Oct 29, 2008 | Oscor, Inc. Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.