510(k) K131079 ยท DYB Introducer, Catheter
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
| Applicant | Creganna Medical Devices, Northborough MA, US |
| Decision | Substantially Equivalent, Aug 1, 2013 |
| Received | Apr 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200 Terminated |
DYB | None listed |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100 Terminated |
DYB | None listed |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400 Terminated |
DYB | None listed |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.