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)
Top companies in DSP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2016 | Arrow 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 |
DSP | K000729 |
| Mar 11, 2016 | Arrow 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 |
DSP | K981660 |
| Mar 11, 2016 | Arrow 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 |
DSP | K000729 |
| Mar 11, 2016 | Arrow 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 |
DSP | K000729 |
| Mar 11, 2016 | Arrow 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 |
DSP | K000729 |
| Mar 11, 2016 | Arrow 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 |
DSP | K021462 |
| Mar 11, 2016 | Arrow 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 |
DSP | K000729 |
| Mar 11, 2016 | Arrow 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 |
DSP | K021462 |
| Dec 16, 2015 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Hybrid and rescue IABP Terminated |
DSP | K112372 |
| Mar 10, 2015 | Arrow International Inc Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB),
8 Fr 40 cc
Model: IAB-05840-LWS Terminated |
DSP | K021462 |
| Mar 2, 2015 | Arrow 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 |
DSP | K021462 |
| Feb 23, 2015 | Maquet Datascope Corp - Cardiac Assist Division Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Terminated |
DSP | K112372 |
| Feb 7, 2015 | Maquet 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 |
DSP | K063525 K112372 |
| Sep 3, 2014 | Datascope Corporation LINEAR 7.5 FR. 40cc IAB Catheter
Maquet Getinge Group Terminated |
DSP | K041281 |
| May 21, 2014 | Maquet 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 |
DSP | K031636 K063525 +1 |
| Apr 6, 2013 | Arrow 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 |
DSP | K000729 K021462 |
| Apr 6, 2013 | Arrow 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 |
DSP | K000729 K021462 |
| Jan 9, 2013 | Maquet 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 |
DSP | K112372 |
| Dec 23, 2010 | Arrow 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 |
DSP | K000729 K021462 |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. FiberOptix IAB Ultra 8 Fr, 40cc
Model: IAB-05840-LWS Terminated |
DSP | K000729 K021462 |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. FiberOptix IAB Sheath, Ultra 8 Fr, 30cc.
Model: IAB-05830-LWS Terminated |
DSP | K000729 K021462 |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc.
Model: IAB-05840-U Terminated |
DSP | K000729 K021462 |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc.
Model: IAB-05830-U Terminated |
DSP | K000729 K021462 |
| Jun 21, 2010 | Datascope Corporation System 98XT/98 Intra-Aortic Balloon Pump
This product was only distributed in India and Hong Kong/China. Terminated |
DSP | None listed |
| Jun 21, 2010 | Datascope Corporation CS300 Intra-Aortic Balloon Pump Terminated |
DSP | K063525 |
| Jun 21, 2010 | Datascope Corporation CS100 Intra-Aortic Balloon Pump. Terminated |
DSP | K031636 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 16, 2009 | Arrow 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 |
DSP | K000729 K010330 +2 |
| Apr 15, 2009 | Datascope 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 |
DSP | K063525 |
| Jan 31, 2008 | Datascope Corp Datascope CS 100 Intra-Aortic Balloon Pump and Datascope
CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430 Terminated |
DSP | K063525 |
| Jan 25, 2008 | Arrow 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 |
DSP | K060309 |
| Jan 25, 2008 | Arrow International Inc ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149 Terminated |
DSP | K965209 |
| Jun 5, 2003 | Datascope 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 |
DSP | K964987 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.