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)
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surger
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surger
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Fail
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Com
Open, Classified		 DSPNone listed
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07,
Open, Classified		 DSPK041281
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08,
Open, Classified		 DSPK041281
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For
Open, Classified		 DSPK041281
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Cor
Open, Classified		 DSPK133074
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute
Open, Classified		 DSPK122628
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary
Open, Classified		 DSPK063525
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For
Open, Classified		 DSPK063525
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-0
Open, Classified		 DSPK120868
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 06
Open, Classified		 DSPK120868
Aug 21, 2020Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Synd
Open, Classified		 DSPK120868
Jun 26, 2020Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Terminated		 DSPK162820
Jun 26, 2020Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Terminated		 DSPK162820
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
Terminated		 DSPK060309
Jun 26, 2020Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Terminated		 DSPK060309
Nov 20, 2019Datascope Corporation
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Terminated		 DSPNone listed
Nov 20, 2019Datascope Corporation
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Terminated		 DSPNone listed
Nov 20, 2019Datascope Corporation
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Terminated		 DSPNone listed
Jul 16, 2019Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Open, Classified		 DSPK151254
Jul 16, 2019Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Open, Classified		 DSPK151254
Jul 16, 2019Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Open, Classified		 DSPK112372
K151254 +2
Jul 16, 2019Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Open, Classified		 DSPK112372
K151254 +2
Jul 16, 2019Datascope Corp.
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
Open, Classified		 DSPK112372
K151254 +2
Jul 16, 2019Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Open, Classified		 DSPK112372
K151254 +2
May 28, 2019Datascope Corporation
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is
Terminated		 DSPK122628
Oct 27, 2018Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Open, Classified		 DSPK181122
Oct 27, 2018Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Open, Classified		 DSPK181122
May 3, 2018Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
Open, Classified		 DSPK112372
K151254
Apr 16, 2018Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation durin
Terminated		 DSPK133074
Apr 16, 2018Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation du
Terminated		 DSPK120868
Apr 16, 2018Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation du
Terminated		 DSPK120868
Jul 17, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pre
Open, Classified		 DSPK151254
Jul 17, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pre
Open, Classified		 DSPK031636
Jul 17, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pr
Open, Classified		 DSPK031636
Jun 23, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 300 Intra-Aortic Balloon Pump
Terminated		 DSPK151254
Jun 23, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 100 Intra-Aortic Balloon Pump
Terminated		 DSPK031636
Jun 23, 2017Maquet Datascope Corp - Cardiac Assist Division
CS 100i Intra-Aortic Balloon Pump
Terminated		 DSPK031636
Apr 12, 2017Datascope Corporation
SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by
Terminated		 DSPK133074
Dec 23, 2016Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Ball
Terminated		 DSPK112372
K151254
May 13, 2016Datascope Corporation
MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Cathete
Terminated		 DSPK120868
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation,
Terminated		 DSPK981660

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