The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Et Hi-flow Soft Tip/et Hi-flow/enhanced Torque St.
| Device ID | K882803 |
| 510k Number | K882803 |
| Device Name: | ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-07 |
| Decision Date | 1988-09-16 |