Atlas FDA

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

FDA 510(k) clearance K112372 · decided 2011-09-15

Clearance details

K-number
K112372
Device name
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
Applicant
Cardiac Assist, Maquet Cardiovascular, LLC
Decision
Substantially Equivalent
Date received
2011-08-17
Decision date
2011-09-15
Days to decision
29 days
Clearance type
Special
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Manwah, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AC3™ Range™ Intra-Aortic Balloon Pump (K250542)Arrow International, LLC2025-03-26
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AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238)Arrow International, Teleflex2019-11-12
UltraFlex IAB (K190101)Arrow International, Inc.2019-06-28
Fiberoptix IAB (K190117)Arrow International, Inc.2019-06-13
CARDIOSAVE Intra-Aortic Balloon Pump (K181122)Datascope Corp.2018-05-31
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305)Datascope Corp.2017-10-12
AC3 Series IABP System (K162820)Arrow International, Inc.2017-03-31
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542)Datascope Corp.2017-01-31
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254)Datascope Corp.2015-07-02

Recalls involving this device

RecordFirmDate
Battery Charging Station; Model: 0998-00-0802; recall (Z-1587-2026)Datascope Corp.2026-03-19
Cardiosave Hybrid recall (Z-0931-2026)Datascope Corp.2025-12-16
Cardiosave Rescue recall (Z-0932-2026)Datascope Corp.2025-12-16
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. recall (Z-0916-2026)Datascope Corp.2025-12-11
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Nu recall (Z-1907-2023)Datascope Corp.2023-06-14
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 recall (Z-1462-2023)Datascope Corp.2023-04-26
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-1276-2023)Datascope Corp.2023-03-22
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-08 recall (Z-1277-2023)Datascope Corp.2023-03-22
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 recall (Z-1278-2023)Datascope Corp.2023-03-22
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Numbe recall (Z-1279-2023)Datascope Corp.2023-03-22
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part nu recall (Z-1145-2023)Datascope Corp.2023-03-09
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part nu recall (Z-1146-2023)Datascope Corp.2023-03-09
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-1229-2023)Datascope Corp.2023-03-06
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00 recall (Z-1230-2023)Datascope Corp.2023-03-06
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-3 recall (Z-0336-2022)Datascope Corp.2021-12-30
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-7 recall (Z-0337-2022)Datascope Corp.2021-12-30
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid recall (Z-0091-2022)Datascope Corp.2021-10-20
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-08 recall (Z-0075-2022)Datascope Corp.2021-10-07
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. recall (Z-1506-2021)Datascope Corp.2021-04-28
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. recall (Z-1507-2021)Datascope Corp.2021-04-28
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use recall (Z-1939-2019)Datascope Corp.2019-07-16
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use. recall (Z-1940-2019)Datascope Corp.2019-07-16
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use. recall (Z-1941-2019)Datascope Corp.2019-07-16
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use. recall (Z-1942-2019)Datascope Corp.2019-07-16
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) recall (Z-1140-2015)Maquet Datascope Corp - Cardiac Assist Division2015-02-23
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile recall (Z-1062-2015)Maquet Datascope Corp - Cardiac Assist Division2015-02-07
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and defla recall (Z-0662-2013)Maquet Cardiovascular, LLC2013-01-09