The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive With V-loop/ Vdrive Duo.
Device ID | K140804 |
510k Number | K140804 |
Device Name: | VDRIVE WITH V-LOOP/ VDRIVE DUO |
Classification | System, Catheter Control, Steerable |
Applicant | STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax, VA 22031 |
Contact | Diane Horwitz, Ph.d., Rac |
Correspondent | Diane Horwitz, Ph.d., Rac STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax, VA 22031 |
Product Code | DXX |
CFR Regulation Number | 870.1290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-31 |
Decision Date | 2014-09-03 |
Summary: | summary |