510(k) K951509 ยท QEY Mechanical Thrombolysis Catheter
PULSE*SPRAY INFUSION SYSTEM
| Applicant | Angiodynamics, Div. E-Z-Em, Inc., Queensbury NY, US |
| Decision | Substantially Equivalent, Jun 16, 1995 |
| Received | Apr 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951509
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 10 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Terminated |
KRA | None listed |
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.