The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Brachial Coronary Guiding Cath W/tapered Tip.
| Device ID | K860580 |
| 510k Number | K860580 |
| Device Name: | ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-18 |
| Decision Date | 1986-03-31 |