The following data is part of a premarket notification filed by Vesatek, Llc with the FDA for Litesaber Wire Torque Assist Device.
Device ID | K200120 |
510k Number | K200120 |
Device Name: | LiteSaber Wire Torque Assist Device |
Classification | Wire, Guide, Catheter |
Applicant | Vesatek, LLC 17171 Daimler Street Irvine, CA 92614 |
Contact | David Look |
Correspondent | Paul Gasser Vesatek, LLC 17171 Daimler Street Irvine, CA 92614 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-21 |
Decision Date | 2020-05-07 |