The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Acat 1 (arrow Cardiac Assist Technology 1).
| Device ID | K965209 |
| 510k Number | K965209 |
| Device Name: | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | Michael Jesi |
| Correspondent | Michael Jesi ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-27 |
| Decision Date | 1998-01-23 |
| Summary: | summary |