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 |