The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries Medical Model 700.
| Device ID | K833632 |
| 510k Number | K833632 |
| Device Name: | ARIES MEDICAL MODEL 700 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARIES MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1984-05-16 |