The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for 40cc Percutaneous Pre-furl (d/l) Balloon Catheter.
| Device ID | K864537 |
| 510k Number | K864537 |
| Device Name: | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Contact | Barry Asher |
| Correspondent | Barry Asher 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 | 1986-11-17 |
| Decision Date | 1987-06-19 |