The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Coronary Infusion Catheter W/sideholes.
| Device ID | K850353 |
| 510k Number | K850353 |
| Device Name: | CORONARY INFUSION CATHETER W/SIDEHOLES |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Contact | Theresa Newton |
| Correspondent | Theresa Newton ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-29 |
| Decision Date | 1985-04-10 |