The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Cross-it 400xt Guide Wire.
Device ID | K992169 |
510k Number | K992169 |
Device Name: | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
Contact | Margaret Anderson |
Correspondent | Margaret Anderson ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-28 |
Decision Date | 1999-10-28 |
Summary: | summary |