The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Viking Guiding Catheter.
Device ID | K972484 |
510k Number | K972484 |
Device Name: | ACS VIKING GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Contact | Sara Toyloy |
Correspondent | Sara Toyloy GUIDANT CORP. 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 | 1997-07-02 |
Decision Date | 1997-09-26 |
Summary: | summary |