The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Ac3 Series Iabp System.
| Device ID | K162820 |
| 510k Number | K162820 |
| Device Name: | AC3 Series IABP System |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTERNATIONAL, INC. 16 ELIZABETH DR Chelmsford, MA 01824 |
| Contact | Alifiya Jagmag |
| Correspondent | Alifiya Jagmag ARROW INTERNATIONAL, INC. 16 ELIZABETH DR Chelmsford, MA 01824 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801902092885 | K162820 | 000 |
| 00801902092878 | K162820 | 000 |
| 00801902092854 | K162820 | 000 |
| 30801902091155 | K162820 | 000 |
| 00801902089441 | K162820 | 000 |
| 00801902089434 | K162820 | 000 |
| 00801902091253 | K162820 | 000 |
| 00801902084965 | K162820 | 000 |
| 20801902143147 | K162820 | 000 |