The following data is part of a premarket notification filed by Arrow International, Teleflex with the FDA for Ac3 Series Intra-aortic Balloon Pump (iabp).
| Device ID | K192238 |
| 510k Number | K192238 |
| Device Name: | AC3 Series Intra-Aortic Balloon Pump (IABP) |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Arrow International, Teleflex 16 Elizabeth Drive Chelmsford, MA 01824 |
| Contact | Deb Fleetham |
| Correspondent | Deb Fleetham Arrow International, Teleflex 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 | 2019-08-19 |
| Decision Date | 2019-11-12 |