The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries 30cc & 50cc Intra-aortic Balloon & Cont. Sys.
| Device ID | K895433 |
| 510k Number | K895433 |
| Device Name: | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Contact | Barry V Ashar |
| Correspondent | Barry V Ashar ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-07 |
| Decision Date | 1990-04-10 |