The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Intraoperative Balloon Dilation Cath..
| Device ID | K822393 |
| 510k Number | K822393 |
| Device Name: | INTRAOPERATIVE BALLOON DILATION CATH. |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-09 |
| Decision Date | 1982-11-01 |