The following data is part of a premarket notification filed by Arrow International Inc. with the FDA for Ac3 Iabp, Ac3 Optimus Iabp, Autocat2 Wave Iabp, Autocat2 Iabp.
| Device ID | K201112 |
| 510k Number | K201112 |
| Device Name: | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Arrow International Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Contact | Shajunath Nirupama |
| Correspondent | Shajunath Nirupama Arrow International Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-05-27 |