The following data is part of a premarket notification filed by Guidant Cardiac And Vascular Surgery with the FDA for Guidant Retriever Device.
Device ID | K001694 |
510k Number | K001694 |
Device Name: | GUIDANT RETRIEVER DEVICE |
Classification | Catheter, Percutaneous |
Applicant | GUIDANT CARDIAC AND VASCULAR SURGERY 1525 O'BRIEN DR. Menlo Park, CA 94025 |
Contact | Bernice Jurs |
Correspondent | Bernice Jurs GUIDANT CARDIAC AND VASCULAR SURGERY 1525 O'BRIEN DR. Menlo Park, CA 94025 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-02 |
Decision Date | 2001-05-15 |