The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Guide Wires With Modified Package Insert.
Device ID | K946029 |
510k Number | K946029 |
Device Name: | ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
Contact | Marianne Drennan |
Correspondent | Marianne Drennan 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 | 1994-12-09 |
Decision Date | 1995-02-24 |