510(k) K021571 ยท MQS System, Hemodialysis, Access Recirculation Monitoring
TRANSONIC FLOW-QC SET MODEL ADT1010
| Applicant | Transonic Systems, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Aug 12, 2002 |
| Received | May 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Transonic Systems Inc Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40
The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be us Terminated |
PEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.