510(k) K022536 ยท KOC Accessories, Blood Circuit, Hemodialysis
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
| Applicant | Fresenius Medical Care, Lexington MA, US |
| Decision | Substantially Equivalent, Oct 30, 2002 |
| Received | Aug 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2015 | Fresenius Medical Care Holdings, Inc. Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume ca Terminated |
KOC | None listed |
| Jan 23, 2009 | Fresenius Medical Care North America CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Product Code: 03-2994-6 24 sets / case
CombiSet Bloodl Terminated |
KOC | None listed |
| Jan 23, 2009 | Fresenius Medical Care North America CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Product Code: 03-2794-0
Bonded CombiSets - includes pri Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.