Company
Arrow International, Inc., Division of Teleflex Medical Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 14 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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-S7IT
The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, Terminated |
DSP | K981660 |
| 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 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 |