510(k) K040801 ยท DSP System, Balloon, Intra-Aortic And Control
INTRA-AORTIC BALLOON (IAB)
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, May 6, 2004 |
| Received | Mar 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.