The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Magellan Robotic Catheter Ekit.
Device ID | K153304 |
510k Number | K153304 |
Device Name: | Hansen Medical Magellan Robotic Catheter EKit |
Classification | Catheter, Steerable |
Applicant | Hansen Medical, Inc. 800 E Middlefield Road Mountain View, CA 94043 |
Contact | Marysa Loustalot |
Correspondent | Marysa Loustalot Hansen Medical, Inc. 800 E Middlefield Road Mountain View, CA 94043 |
Product Code | DRA |
CFR Regulation Number | 870.1280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-16 |
Decision Date | 2016-02-01 |
Summary: | summary |