ClearanceBrief
Panels › Cardiovascular › Product code DSP · Class 2

System, Balloon, Intra-Aortic And Control

Regulation 870.3535

0510(k)s in 12 months (162 all time)
7recalls in 12 months (194 all time)
181recalls that name a 510(k)
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Top companies in DSP

Company510(k)sRecalls
Datascope Corp.64101
Arrow International, Inc.763
Kontron Instruments, Inc.170
Arrow Intl., Inc.150
Arrow International, Inc., Division of Teleflex Medical Inc.014
Boston Scientific Corp140
Maquet Datascope Corp - Cardiac Assist Division014
Aries Medical, Inc.80
Smec, Inc.70
Belmont Instrument Corp.50
DateFirm and productCodeLinked 510(k)
Mar 19, 2026Datascope Corp.
Battery Charging Station; Model: 0998-00-0802;
Open, Classified		 DSPK112372
Mar 3, 2026Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
Open, Classified		 DSPK063525
K172305
Mar 3, 2026Datascope Corp.
CS100 IABP. Software Version CS100 IABP Q.01.
Open, Classified		 DSPK031636
K172305
Dec 16, 2025Datascope Corp.
Cardiosave Rescue
Open, Classified		 DSPK112372
K151254 +2
Dec 16, 2025Datascope Corp.
Cardiosave Hybrid
Open, Classified		 DSPK112372
K151254 +2
Dec 11, 2025Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Open, Classified		 DSPK163542
Dec 11, 2025Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Open, Classified		 DSPK112372
K151254 +1
Aug 13, 2025Insightra Medical Inc
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Descriptio
Terminated		 DSPK082746
Nov 5, 2024Datascope Corp.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Open, Classified		 DSPK041281
K112327 +1
Sep 20, 2024Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified		 DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified		 DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified		 DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified		 DSPK181122
Jun 3, 2024ARROW INTERNATIONAL Inc.
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Open, Classified		 DSPK000729
K993966
Jun 3, 2024ARROW INTERNATIONAL Inc.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Open, Classified		 DSPK000729
K190101
Jun 3, 2024ARROW INTERNATIONAL Inc.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Open, Classified		 DSPK200634
Aug 31, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Aug 31, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified		 DSPK181122
Jul 21, 2023Datascope Corp.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK041281
Jul 21, 2023Datascope Corp.
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK133074
Jul 21, 2023Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK122628
Jul 21, 2023Datascope Corp.
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK133074
Jul 21, 2023Datascope Corp.
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK120868
Jul 21, 2023Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number
Open, Classified		 DSPNone listed
Jul 21, 2023Datascope Corp.
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DSPK063525
Jul 21, 2023Datascope Corp.
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description
Open, Classified		 DSPNone listed
Jul 20, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified		 DSPK181122
Jul 20, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-
Open, Classified		 DSPK181122
Jul 19, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified		 DSPK181122
Jul 19, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-
Open, Classified		 DSPK181122
Jun 14, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Open, Classified		 DSPK112372
Apr 26, 2023Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Open, Classified		 DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Open, Classified		 DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Open, Classified		 DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55
Open, Classified		 DSPK112372
Mar 9, 2023Datascope Corp.
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified		 DSPK181122
Mar 9, 2023Datascope Corp.
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0
Open, Classified		 DSPK181122
Mar 9, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified		 DSPK112372
Mar 9, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0
Open, Classified		 DSPK112372
Mar 6, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Open, Classified		 DSPK112372
Mar 6, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53
Open, Classified		 DSPK112372

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