The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Powerbase Guilding Catheter.
Device ID | K952205 |
510k Number | K952205 |
Device Name: | ACS POWERBASE GUILDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Contact | Martha Reitman |
Correspondent | Martha Reitman ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-10 |
Decision Date | 1995-08-04 |