510(k) K201112 ยท DSP System, Balloon, Intra-Aortic And Control
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
| Applicant | Arrow International, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, May 27, 2020 |
| Received | Apr 27, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.