510(k) K033569 ยท KRA Catheter, Continuous Flush
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
| Applicant | Flowmedica, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jan 13, 2004 |
| Received | Nov 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.