The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Sensei Robotic Catheter System, Model 02057.
Device ID | K091808 |
510k Number | K091808 |
Device Name: | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 |
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 | 2009-06-18 |
Decision Date | 2009-09-10 |
Summary: | summary |