510(k) K831591 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
AORTIC ROOT CANNULA W/INTEGRAL PRESS
| Applicant | Dlp, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 30, 1983 |
| Received | May 17, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Cardioplegia Adapter with Pressure Port
Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with t Terminated |
DWF | None listed |
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Pressure Monitoring Extension Line Adapters
Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.