The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Soft-tip Coronary Infusion Cath W/side Holes.
| Device ID | K883564 |
| 510k Number | K883564 |
| Device Name: | ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Kevyn B O'connor |
| Correspondent | Kevyn B O'connor 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 | 1988-08-22 |
| Decision Date | 1988-11-03 |