510(k) K021462 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, Jun 6, 2002 |
| Received | May 7, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| Mar 10, 2015 | Arrow International Inc Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB),
8 Fr 40 cc
Model: IAB-05840-LWS Terminated |
DSP | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. FiberOptix IAB Sheath, Ultra 8 Fr, 30cc.
Model: IAB-05830-LWS Terminated |
DSP | None listed |
| Dec 23, 2010 | Arrow International, Inc., Division of Teleflex Medical Inc. FiberOptix IAB Ultra 8 Fr, 40cc
Model: IAB-05840-LWS Terminated |
DSP | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.