510(k) K981909 ยท DYB Introducer, Catheter
BAXTER HEMOSTASIS VALVE INTRODUCERS
| Applicant | Baxter Edwards, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 24, 1998 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Edwards Lifesciences, LLC Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for Terminated |
DWF | None listed |
| Jul 11, 2011 | Edwards Lifesciences, LLC Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for Terminated |
DWF | None listed |
| Aug 25, 2009 | Edwards Lifesciences, Llc Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only.
Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.