The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Et Hi-flow/enhanced Torque Coronary Guid Cath.
Device ID | K926421 |
510k Number | K926421 |
Device Name: | ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH |
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 | 1992-12-23 |
Decision Date | 1993-03-23 |