The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Magellan Robotic Catheter 6fr And Accessory Components.
Device ID | K151463 |
510k Number | K151463 |
Device Name: | Hansen Medical Magellan Robotic Catheter 6Fr And Accessory Components |
Classification | Catheter, Steerable |
Applicant | HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
Contact | Elisa Aldridge |
Correspondent | Elisa Aldridge HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
Product Code | DRA |
CFR Regulation Number | 870.1280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-01 |
Decision Date | 2015-08-18 |
Summary: | summary |