510(k) K924529 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SIGNATURE(TM) CUSTOM TUBING PACK
| Applicant | Avecor Cardiovascular, Inc., Plymouth MN, US |
| Decision | Unknown, Jun 23, 1993 |
| Received | Sep 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2016 | Medtronic Inc Affinity Fusion" Oxygenator with Integrated Arterial Filter,
Affinity Fusion cardiotomy/Venous Reservoir,
Perfusion Tubing Packs
The Affinity Fusion Oxygenator with Integrated Arterial Filter with or Terminated |
DTZ | None listed |
| Feb 26, 2016 | Medtronic Perfusion Systems Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO.
Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.