510(k) K082163 ยท KRA Catheter, Continuous Flush
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
| Applicant | Flowmedica, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Oct 29, 2008 |
| Received | Jul 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | None listed |
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | None listed |
| Feb 28, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, Terminated |
KRA | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; Terminated |
KRA | None listed |
| May 28, 2010 | Angiodynamics, Inc. ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queens Terminated |
KRA | None listed |
| May 28, 2010 | Angiodynamics, Inc. ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Catalog/Model/REF Number 60035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 6 Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.