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 |