510(k) K133658 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
CDI BLOOD PARAMETER MONITORING SYSTEM 500
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 25, 2014 |
| Received | Nov 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2018 | Terumo Cardiovascular Systems Corporation CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883
Product Usage:
The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon Terminated |
DRY | None listed |
| Jun 26, 2018 | Terumo Cardiovascular Systems Corporation Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT
Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT
Product Usage:
The CDI System 500 provides continuous, on-lin Terminated |
DRY | None listed |
| Mar 25, 2016 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Cardiopulmonary bypass on-line blood gas monitor
Product Usage:
The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pre Terminated |
DRY | None listed |
| Sep 9, 2015 | Terumo Cardiovascular Systems Corporation CDI 500 Blood Parameter Monitoring System.
Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit Terminated |
DRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.