Atlas FDA

3M CDI BLOOD PARAMETER MONITORING SYSTEM 500

FDA 510(k) clearance K972962 · decided 1997-11-06

Clearance details

K-number
K972962
Device name
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1997-08-11
Decision date
1997-11-06
Days to decision
87 days
Clearance type
Traditional
Product code
DRY
Device class
2
Regulation number
870.4330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tustin, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; recall (Z-1634-2014)Terumo Cardiovascular Systems Corporation2014-05-19
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-1730-2013)Terumo Cardiovascular Systems Corporation2013-07-13
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hemato recall (Z-1731-2013)Terumo Cardiovascular Systems Corporation2013-07-13
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-1732-2013)Terumo Cardiovascular Systems Corporation2013-07-13
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended f recall (Z-1733-2013)Terumo Cardiovascular Systems Corporation2013-07-13
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for recall (Z-1734-2013)Terumo Cardiovascular Systems Corporation2013-07-13
CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmona recall (Z-1378-2012)Terumo Cardiovascular Systems Corporation2012-04-06
CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonar recall (Z-1379-2012)Terumo Cardiovascular Systems Corporation2012-04-06
CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary recall (Z-1380-2012)Terumo Cardiovascular Systems Corporation2012-04-06
CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary b recall (Z-1381-2012)Terumo Cardiovascular Systems Corporation2012-04-06
CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary b recall (Z-1382-2012)Terumo Cardiovascular Systems Corporation2012-04-06
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0672-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0673-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0674-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitorin recall (Z-0675-2012)Terumo Cardiovascular Systems Corporation2012-01-11
CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalo recall (Z-0142-2012)Terumo Cardiovascular Systems Corporation2011-10-31
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and recall (Z-2678-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blo recall (Z-2679-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and recall (Z-2680-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blo recall (Z-2681-2011)Terumo Cardiovascular Systems Corporation2011-06-28
Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood recall (Z-2682-2011)Terumo Cardiovascular Systems Corporation2011-06-28
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-2185-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematoc recall (Z-2186-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules recall (Z-2187-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog num recall (Z-2188-2011)Terumo Cardiovascular Systems Corporation2011-05-12
CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog numbe recall (Z-2189-2011)Terumo Cardiovascular Systems Corporation2011-05-12

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22