510(k) K083269 ยท DYB Introducer, Catheter
CROSSOVER
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Nov 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2009 | Thomas Medical Products Inc Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Terminated |
DYB | None listed |
| Nov 5, 2009 | Cordis Corporation Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA.
Distributed by Cordis Corporation, 14201 North West 60th Avenue, Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.