The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Guide Wire.
Device ID | K821190 |
510k Number | K821190 |
Device Name: | GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-27 |
Decision Date | 1982-08-31 |