510(k) K972962 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
| Applicant | 3M Company, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 6, 1997 |
| Received | Aug 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2014 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535) Terminated |
DRY | None listed |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.
Intended for use during cardiopulmonary bypass procedures when continuous m Terminated |
DRY | None listed |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring Terminated |
DRY | None listed |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or veno Terminated |
DRY | None listed |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2 Terminated |
DRY | None listed |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AVHCT.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AHCT.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AV.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500A.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500V.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | None listed |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | None listed |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | None listed |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | None listed |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | None listed |
| Oct 31, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.
Catalog Numbe Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT. Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT. Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV. Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module, catalog 500A. Terminated |
DRY | None listed |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V. Terminated |
DRY | None listed |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. Terminated |
DRY | None listed |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 50 Terminated |
DRY | None listed |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems
The CDI 500 is indicated for use to display patient blood gas Terminated |
DRY | None listed |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 500 is indicated for use Terminated |
DRY | None listed |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 500 is indicated for use Terminated |
DRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.