510(k) K905447 ยท KRA Catheter, Continuous Flush
E-Z-EM PULSED INFUSION SYSTEM
| Applicant | E-Z-Em, Inc., Worcester MA, US |
| Decision | Substantially Equivalent, Apr 1, 1991 |
| Received | Dec 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2014 | Angiodynamics, Inc. Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128 Terminated |
KRA | None listed |
| Aug 18, 2014 | Angiodynamics, Inc. Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128 Terminated |
KRA | None listed |
| Aug 18, 2014 | Angiodynamics, Inc. Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128 Terminated |
KRA | None listed |
| May 27, 2010 | Angiodynamics, Inc. PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804.
Infusion Catheter. Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.