The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Enhanced-torque Coronary Guiding Catheter.
| Device ID | K871425 |
| 510k Number | K871425 |
| Device Name: | ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Jane E Beggs |
| Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-08 |
| Decision Date | 1987-05-22 |