510(k) K902654 ยท DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
CDI (TM) SYSTEM 100 MONITORING SYSTEM
| Applicant | 3M Health Care, Ltd., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 5, 1990 |
| Received | Jun 15, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101. Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100. Terminated |
DRY | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System,
The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedu Terminated |
DRY | None listed |
| Apr 11, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Terminated |
DTY | None listed |
| Apr 11, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Terminated |
DTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.