Atlas FDA

CARDIOSAVE Intra-Aortic Balloon Pump

FDA 510(k) clearance K181122 · decided 2018-05-31

Clearance details

K-number
K181122
Device name
CARDIOSAVE Intra-Aortic Balloon Pump
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
2018-04-30
Decision date
2018-05-31
Days to decision
31 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
AC3™ Series IABP (K232343)Arrow International, LLC2023-08-30
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112)Arrow International, Inc.2020-05-27
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (K200634)Arrow International, Inc.2020-04-09
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
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
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES (K133074)Datascope Corp.2013-12-12

Recalls involving this device

RecordFirmDate
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 PUMP (IABP). Electromechanical system used to infla recall (Z-3134-2024)Datascope Corp.2024-09-20
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3135-2024)Datascope Corp.2024-09-20
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3136-2024)Datascope Corp.2024-09-20
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3137-2024)Datascope Corp.2024-09-20
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2486-2023)Datascope Corp.2023-08-31
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2487-2023)Datascope Corp.2023-08-31
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2431-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2432-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2433-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2434-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2435-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2436-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2437-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2438-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00- recall (Z-2151-2023)Datascope Corp.2023-07-20
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00- recall (Z-2152-2023)Datascope Corp.2023-07-20
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00- recall (Z-2149-2023)Datascope Corp.2023-07-19
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00- recall (Z-2150-2023)Datascope Corp.2023-07-19
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800- recall (Z-1147-2023)Datascope Corp.2023-03-09
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 recall (Z-1148-2023)Datascope Corp.2023-03-09
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800- recall (Z-1231-2023)Datascope Corp.2023-03-06
Cardiosave Rescue. Model Number: 0998-00-0800-83. recall (Z-1232-2023)Datascope Corp.2023-03-06
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-0885-2023)Datascope Corp.2023-01-19
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00 recall (Z-0886-2023)Datascope Corp.2023-01-19
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 Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-08 recall (Z-0076-2022)Datascope Corp.2021-10-07
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
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 recall (Z-0099-2019)Maquet Datascope Corp - Cardiac Assist Division2018-10-27
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 recall (Z-0100-2019)Maquet Datascope Corp - Cardiac Assist Division2018-10-27

PMA approvals by this applicant

RecordFirmDate
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010)Datascope Corp.1992-11-16
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013)Datascope Corp.1992-08-26
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009)Datascope Corp.1990-09-28
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005)Datascope Corp.1989-05-17
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008)Datascope Corp.1989-03-09
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006)Datascope Corp.1988-09-09