The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Artisan S Control Catheter.
Device ID | K090365 |
510k Number | K090365 |
Device Name: | HANSEN MEDICAL ARTISAN S CONTROL CATHETER |
Classification | System, Catheter Control, Steerable |
Applicant | HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
Contact | Kate Whitin |
Correspondent | Kate Whitin HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
Product Code | DXX |
CFR Regulation Number | 870.1290 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-13 |
Decision Date | 2009-05-07 |
Summary: | summary |