The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries 40cc Percu. (d/l) Intra-aortic Balloon Cath..
| Device ID | K882289 |
| 510k Number | K882289 |
| Device Name: | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| 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 | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-12-12 |