510(k) K981660 ยท DSP System, Balloon, Intra-Aortic And Control
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
| Applicant | C.R. Bard, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, Oct 16, 1998 |
| Received | May 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Mar 11, 2016 | Arrow 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 |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.