The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs 0.015 & 0.018 Pressure Guide Wire W/micro..
Device ID | K882507 |
510k Number | K882507 |
Device Name: | ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO. |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Michael C Kolber |
Correspondent | Michael C Kolber ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-17 |
Decision Date | 1989-03-31 |