510(k) K073559 ยท DQR Cannula, Catheter
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
| Applicant | Edwards Lifesciences Research Medical, Midvale UT, US |
| Decision | Substantially Equivalent, Jan 31, 2008 |
| Received | Dec 19, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI16
Software Version: N/A
Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per Open, Classified |
DQR | None listed |
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI18
Software Version: N/A
Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per Open, Classified |
DQR | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. Terminated |
DQR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.