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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

DateFirm and productCodeLinked 510(k)
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPK000729
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, du
Terminated
DSPK981660
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPK000729
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation
Terminated
DSPK000729
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, du
Terminated
DSPK000729
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and
Terminated
DSPK021462
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, du
Terminated
DSPK000729
Mar 11, 2016Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole inc
Terminated
DSPK021462
Dec 16, 2015Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid and rescue IABP
Terminated
DSPK112372
Mar 10, 2015Arrow International Inc
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Terminated
DSPK021462
Mar 2, 2015Arrow International Inc
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon
Terminated
DSPK021462
Feb 23, 2015Maquet Datascope Corp - Cardiac Assist Division
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Terminated
DSPK112372
Feb 7, 2015Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998
Terminated
DSPK063525
K112372
Sep 3, 2014Datascope Corporation
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Terminated
DSPK041281
May 21, 2014Maquet Datascope Corp - Cardiac Assist Division
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Terminated
DSPK031636
K063525 +1
Apr 6, 2013Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Terminated
DSPK000729
K021462
Apr 6, 2013Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Terminated
DSPK000729
K021462
Jan 9, 2013Maquet Cardiovascular, LLC
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpuls
Terminated
DSPK112372
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
Terminated
DSPK000729
K021462
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
Terminated
DSPK000729
K021462
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
Terminated
DSPK000729
K021462
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
Terminated
DSPK000729
K021462
Dec 23, 2010Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
Terminated
DSPK000729
K021462
Jun 21, 2010Datascope Corporation
System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.
Terminated
DSPNone listed
Jun 21, 2010Datascope Corporation
CS300 Intra-Aortic Balloon Pump
Terminated
DSPK063525
Jun 21, 2010Datascope Corporation
CS100 Intra-Aortic Balloon Pump.
Terminated
DSPK031636
Apr 16, 2009Arrow International, Inc.
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastol
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dias
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during dia
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy,
Terminated
DSPK000729
K010330 +2
Apr 16, 2009Arrow International, Inc.
8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy,
Terminated
DSPK000729
K010330 +2
Apr 15, 2009Datascope Corporation
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
Terminated
DSPK063525
Jan 31, 2008Datascope Corp
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
Terminated
DSPK063525
Jan 25, 2008Arrow International Inc
AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149
Terminated
DSPK060309
Jan 25, 2008Arrow International Inc
ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
Terminated
DSPK965209
Jun 5, 2003Datascope Corp
10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which wo
Terminated
DSPK964987

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