Atlas FDA

CONTINUOUS CARDIAC OUTPUT SYSTEM

FDA 510(k) clearance K932414 · decided 1994-11-14

Clearance details

K-number
K932414
Device name
CONTINUOUS CARDIAC OUTPUT SYSTEM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1993-05-19
Decision date
1994-11-14
Days to decision
544 days
Clearance type
Traditional
Product code
DXG
Device class
2
Regulation number
870.1435
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord manufacture recall (Z-0142-2010)Hospira Inc2009-11-09
Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235 recall (Z-0145-2010)Hospira Inc2009-11-09
Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 5 recall (Z-0146-2010)Hospira Inc2009-11-09
Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 522 recall (Z-0147-2010)Hospira Inc2009-11-09

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30