510(k) K001139 ยท DYB Introducer, Catheter
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, May 10, 2000 |
| Received | Apr 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001139
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS Terminated |
DYB | None listed |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M Terminated |
DYB | None listed |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M Terminated |
DYB | None listed |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A Terminated |
DYB | None listed |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.